Engineer, Quality Resume Sample
Abe Schowalter
9517 Nikita Lakes,
Boston,
MA
+1 (555) 142 3274
Work Experience
Principal Engineer, Quality
04/2017
-
PRESENT
San Francisco, CA
- Review, approve and release work instructions/procedures. Understand and interpret required engineering drawings, specifications and technical manuals. Verify compliance with applicable drawings, specifications, procedures, and government requirements
- Coordinate disposition of non-conforming material identified
- Drive risks assessment (DFMEA/PFMEA) and deploy problems solving methodology (8D’s)
- Facilitate RCA's & NCCA's Attend Final Product Audit Review and Audit Disposition
- Lead the investigation, resolution and prevention of product and process nonconformances
- Define and balance resources needed to support the programs demands
- Create and deliver program status, investigation and other presentations to program and functional management
Engineer, Quality
10/2012
-
01/2017
Chicago, IL
- Establishes safe launch process for new parts, reviews data on a regular basis, drives process
- Participation in change management activities and ensures changes are properly managed, approved
- Advanced understanding of quality systems, statistical techniques, and risk management (considered the ‘go to’ technical person)
- The ability to work in a team environment and a high level of self-motivation
- Is able to apply, analyze, evaluate and create situations related to regulatory, documentation, design, risk analysis, audit, corrective action, product development, pre and post market, and supplier management requirements
- Is looked to as a leader and expert in three or more functional areas of Quality and Regulatory
- Is able to lead, train and develop new strategies, processes and policies as it relates to good manufacturing practice requirements, validation, design input, rework, audits, complaint, component and control
- Is able to initiate, create and evaluate methods, definitions, and principles as it relates to their functional area of quality and is able to transfer and share that knowledge and experience to the newer members of the team
Product Reliability Engineer Quality
03/2009
-
04/2012
Boston, MA
- Translates strategy into executable plans by working collaboratively across functions and with management team
- Effectively drives change, leading and inspiring team members to move from ideas and strategy into action, refining execution of plans as appropriate
- Is able to determine, lead, and teach as it relates to the appropriate standard quantitative methods such metrology, data analysis, Statistical Process Control, etc. across a spectrum of business environments to facilitate process analysis and improvements
- Is able to review, analyze and change, procedures and documentation to their functional area and cross functionally as deemed necessary by governmental changes
- Effectively identifies and manages talent that drives the collaborative culture required for achieving success
- Develop a team environment that values diversity and uses various individual’s strengths to the benefit of the team
- Provides direction on the development and exploration of new and innovative products, services and partnerships that drive growth and leverage Invacare's worldwide capabilities
- Leads projects to drive continuous improvement processes within the function and cross functionally
- Drives results with the use of new technologies or techniques and generates multiple potential solutions
Education
Western New England University
2004 - 2008
Engineer's Degree in Engineering
Professional Skills
- Identify and coordinate quality and process improvement initiatives in your area to assure that product, processes, and systems are all being reviewed, assessed, and improved
- Strong critical thinking skills, and ability in handling detailed information/data skills
- Strong documentation, communication and interpersonal skills including negotiating and relationship management skills
- Customer focus attitude, process management skills, drive for results, conflict management skills
- Strong interpersonal skills and the ability to effectively facilitate, lead and manage small teams
- Decision making skills, creativity, ability to set priorities and building effective teams
- Demonstrated competence in clearly expressing concepts and ideas orally and in writing and have good interpersonal skills
How to write Engineer, Quality Resume
Engineer, Quality role is responsible for excel, interpersonal, microsoft, analysis, english, analytical, basic, software, reporting, training.
To write great resume for engineer, quality job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Engineer, Quality Resume
The section contact information is important in your engineer, quality resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Engineer, Quality Resume
The section work experience is an essential part of your engineer, quality resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous engineer, quality responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular engineer, quality position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Engineer, Quality resume experience can include:
- Strong problem solving skills and ability to develop solutions to
- Strong communication, documentation, problem solving and teamwork skills
- Self-directed individual with proven verbal and written communication skills
- Good statistical and analytical skills
- Verbal and written communication skills that demonstrate the ability to express ideas and exchange information clearly and concisely
- Familiarity with SPC (Statistical Process Control) Strong MS Office skills, particularly in Excel
Education on an Engineer, Quality Resume
Make sure to make education a priority on your engineer, quality resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your engineer, quality experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Engineer, Quality Resume
When listing skills on your engineer, quality resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical engineer, quality skills:
- Good verbal and written communication skills demonstrated by ability to generate technical reports, and presentations for management
- Good time/priority management skills
- Solid problem-solving, organizational, analytical, and critical thinking skills
- Excellent communication skills. Willing to consider recent grads
- Strong written and verbal English communication skills with the ability to communicate cross functionally with both salary and wage workforce
- Excellent oral, written and inter personal communications skills
List of Typical Experience For an Engineer, Quality Resume
1
Experience For Engineer Quality Resume
- We need an excellent communicator with experience and knowledge in the quality field
- Strong basic statistics experience
- Specific Position experience working in a manufacturing environment
- Experience in driving a closed loop corrective action process, including rigorous root cause analysis
- Be familiar with problem solving skill
- Ideally looking for 1-3 years experience, open to recent grads
- Previous Design Assurance and/or Quality engineering with Medical Devices and demonstrated use of Quality tools/methodologies
- Experienced in data mining to create required charts/metrics
- Quality System knowledge/Experience
2
Experience For Principal Engineer, Quality Resume
- Cooperates with process engineers of HPO in order to supervise and control the documentation system of production
- Assists test method development/validation activities
- Ensuring that lessons learned are gathered and are fed back into new development activitie
- Training PQC and FQC on visual inspection and control point
- Monitoring Field service tools calibration and upload the data in AIMS
- Conducting internal audits in Field service and provide data to MR
- Willing to travel in MENA region if any field service request by supervisors
- Set direction, motivate and develop team members secure appropriate training, also assigning progressively challenging tasks
- Support the Product Assurance goal of driving making quality a competitive advantage
3
Experience For Engineer, Quality Senior Resume
- Lead the Root Cause Analysis and Corrective/Preventative action processes, utilizing problem solving tools within an 8D methodology
- Performs quality audits, including supporting International Standards Organization ISO audits, and maintains quality manual
- Provide training and direction to manufacturing and QA personnel
- Lead CAPA, ICS, and RFA detailed data analysis, trending, and reporting. Publish weekly, monthly, and quarterly metrics
- Be familiar with Lean manaufacturing and Kaizen
- Carry out daily, weekly, monthly quality reporting. Identify and target improvement point with closely follow up
4
Experience For Product Reliability Engineer Quality Resume
- Provide the necessary internal and external training to design and related team about obligatory procedure and requirments
- Coordinates and collaborates with global, regional and local quality teams. Also with regulatory affairs, legal, marketing and customer service functions
- Builds quality into all aspects of work by maintaining compliance to all quality and regulatory requirements
- At least 60% of studies completed in Bacherlor in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Field Related
- Regulates quality records, forms and archiving
- Led manufacturing stability project to achieve zero excursion
5
Experience For Industrial Engineer / Quality Resume
- Participates with the Program Engineer in the development ofDFMEA's by taking into
- Lead APQP as part of the New Product Introduction teams, including project risk management activities
- Provide technical assistance in the development and implementation of robust processes to meet customer requirements, including QA plans and process routings
- Submits tags through customer portal to request disposition of nonconforming items
- Understand testing requirements and certifications required for QA/FAI and product
- Possesses understanding of process flow within quality department
- Preparation of Engineering Changes
- Conversant with software applications for Microsoft Windows including Word, Excel, and Access
6
Experience For Project Engineer, Quality Resume
- Execute and provide on-time completion of Quality Assurance engineering deliverables
- Anticipated or recognizes the existence of a problem and makes difficult decisions even in highly ambiguous or ill-defined situations
- Leads investigation teams through root cause analysis of customer complaints and quality system failures
- Drives implementation and follow-up of corrective actions for investigation findings. Initiates regular discussion & correspondence with customers and departments for closure to customer complaints and corrective action requests
- Captures and records Voice of the Customer data for tracking and trending
- Issues internal quality communications (i.e. Quality Alerts)
- Performs risk based audits of quality systems based on the Voice of the Customer data
7
Experience For Improvement Engineer Quality Resume
- Displays and communicates Voice of the customer information on a weekly basis. Issues monthly report to organization that includes customer complaint rates and internal defect and micro rates
- Performs work that requires knowledge and experience in the field of quality engineering that includes a variety of complex technical problems, risk analysis, innovation and coordination requirements to complete assignments
- Problem prevention champion that facilitates and provides expertise in the development and the use of FMEA’s, control plans, inspection material, qualification plans for processes, products and equipment changes
- Problem solving champion responsible for effective corrective actions that result in elimination of occurrence. Ability to lead teams and educate people on the use of problem solving tools contribution to a culture where everyone has a part in continuous improvement
- Capable of identifying, acquiring and analyzing data using appropriate standard quantitative methods across a spectrum of business areas to facilitate process analysis improvements. Comfortable with both Lean and Six Sigma tools to aid in the accomplishment
- Communication skills which are used to understand and develop relationships with Customers to profitably anticipate, satisfy and exceed their needs
- Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes
- Convince and influence skills
- Experience in managing people is desirable
8
Experience For External Engineer, Quality Resume
- Previous experience in industry desirable
- Expert on 8D and DMAIC approaches. Always response to customer quickly with effectiveness
- Supports Molex Global Lean Six Sigma (GLSS) and TQM program by following approved policies and procedures
- Work closely with commodity management team as a supplier quality engineering resource. Includes active participation and leadership in supplier development, auditing, part approvals, launch performance, ongoing production quality and optimization of supply base
- Developing proficiency in statistical methods and application
9
Experience For Lead Engineer Quality Resume
- Understanding of Med Device concepts desirable
- Ensures that department SOP's are up to date and meet appropriate needs and applicable standards. Implements changes to SOP's as required
- Works with other departments to provide technical support
- For specific hardware products, establish and maintain Customer/Field quality metrics, improvement goals, as well as facilitation of improvement actions to ensure a continuous field quality improvement infrastructure
- Interpret and evaluate the product analysis, and recommend the need for additional actions including initiating CAPA’s and working with EM partners to drive their closure
- Have a good understanding of engineering and quality concepts / theories
- Not less than 8 years of working experience of automotive field,5 years focus on the Industrial Engineering and 3 year focus on quality control
10
Experience For Principle Engineer Quality Resume
- Experience in quality engineering tool (ex. PFMEA, Control Plans, Capability Studies, etc)
- Works closely with EM quality assurance personnel on performing product evaluation, final analysis, reporting of such analysis and CAPA’s
- Develop protocols/plans/procedures/requirements for testing of returned customer complaint units in support of company’s quality program
- Participate in both Design and Process Failure Modes and Effects Analysis to ensure that product and process risk are identified and mitigated to allow efficient and effective manufacturing within the constraints of customer and company requirements
- Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections
- Support manufacturing transfers to other plants/facilities, execution quality activities
- Define and publish the quality plan and its execution in new product introduction activities, adhering to Rockwell’s product development process
- Perform statistical experiments such as product qualification testing, process capability studies, and fitness-for-use analysis
- Work on a variety of problems of diverse scope and complexity where analysis and evaluation of various outcomes require tradeoffs and negotiation
List of Typical Skills For an Engineer, Quality Resume
1
Skills For Engineer Quality Resume
- Demonstrated Skills in Root Cause Analysis & Corrective Action (8D)
- Strong communication skills Work with team of auditors Possess a technical strength
- Excellent verbal, written and listening English skills
- Demonstrated experience in managing process and/or systems change
- Min 3 years related working experience as Quality Eng. Good command of written and spoken English
- Work effectively across language and cultural barriers
- Select, develop and evaluate CMM and VMS Operators/inspectors to assure skills align with job expectations
2
Skills For Principal Engineer, Quality Resume
- In addition, we require: - Project management and problem solving skills
- Superior computer skills. Proficient in Microsoft office tools – Specifically Excel and Power Point
- Desired knowledge: Statiscal skills, ASQ Certified, Knowledge of Six Sigma, Knowledge of Lean, APQP or similar
- Statistical Skills, ASQ Certifield, Knowledge of Six Sigma, Knowledge of Lean, APQP or similar
- Working knowledge of 21 CFR 820, ISO 13485, ISO 9001, Quality tools, problem solving tools, and statistical techniques and application experience
- Working knowledge/experience of low power (e.g. GFCT) and high power (e.g. Common Mode Choke) magnetics
3
Skills For Engineer, Quality Senior Resume
- Strong knowledge of process mapping, value chain mapping, value stream mapping and documentation
- Experience in one or more related engineering areas: industrial, production, reliability, design, manufacturing, quality
- Experience in the practice of quality engineering tools, including Supplier Audits, DPAR's, and Design Reviews
- Experience solving manufacturing issues
- Hands-on experience in Data Analysis, preparing reports and driving action plans
- Skilled in the reading and interpretation of engineering drawings and specifications
- Proven track record ofleading and managing quality initiatives that have resulted in improved product
- Professional experience related to assembling, steel machining
- Collaborates with the R&D organization to investigate product failures encountered during the design verification/validation testing
4
Skills For Product Reliability Engineer Quality Resume
- Experience executing to the 8D corrective action process (NCCA)
- Experience in the Medical Device or Engineering Industry
- Experience related to Calibration, Inspection, Quality Control, or a manufacturing environment is required
- Experience auditing quality systems
- Shop floor experience in a manufacturing environment
- Experience in use of statistical tools and techniques for quality management
- Intimate familiarity with ISO9000/TL9000 Quality Systems with implementation or other applicable professional experience
- Hands on experience in in quality tools like SPC, SQC,3 legged 5why
5
Skills For Industrial Engineer / Quality Resume
- Evaluate product and process changes for qualification and validation requirements and assist in change implementations
- Experience with data analysis in Minitab or similar program
- Consolidate customized quality report
- Good knowledge in Semiconductor process
- Collaborates with the R&D organization for develop specification, and design verification/ validation activities
- Pulls data, analyzes and graphs metrics to show QE processes are effective
6
Skills For Project Engineer, Quality Resume
- Mechanical Engineer (desired) or equiv experience
- Identidy the currently procdure and process gaps from the roll out experience, define the actions to improvde process value and effect
- Warranty analysis experience with ability to understand warranty and review failed components
- Work independently, to stay on top of current business conditions, to prioritize projects, multi-task and meet deadlines
- Assures compliant solutions, estimates cost savings. Verifies effectiveness and tracks cost savings
7
Skills For Improvement Engineer Quality Resume
- Supports departmental, functional, divisional, and corporate quality goals and priorities
- Ownership of projects with demonstrated technical competence
- Executes validation studies on equipment and processes, and conducts and/or participates in complaints investigations
- Understanding of Control Plans and PFMEAs Manufacturing Statistical Methods (Control Charting / Capability Analysis)
- Working knowledge of problem solving tools (i.e. process mapping, histograms, FMEA, risk assessment, cause & effect diagrams, PDCA, Pareto analysis, etc.)
- Liaising with purchasing and with suppliers to resolve any supplier certification issues
8
Skills For External Engineer, Quality Resume
- Understanding of Mistake Proofing Techniques
- Monitoring & conducting process capability – CPk/PPk, SPC, Gage R&R etc
- Working knowledge of automotive quality customer requirements
- Liaising with production and other departments to resolve queries
- Liaising with customers to resolve any certification issues
- Conducting internal audits based on TL9000
9
Skills For Lead Engineer Quality Resume
- Helping to support the continuous improvement group
- Contributing to a data driven decision making process and visualising problems, progress and results
- Responsible for planning, organizing and managing the overall activities of receiving/outgoing
- Responsibilities include assisting with on-site audits, evaluating prototypes, and reviewing and approving of supplier corrective actions
- Devise sampling procedures and design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data
- Assist in developing, deploying, and standardizing divisional quality systems
- Familiar with manufacturing process planning and ability to ensure compliance with drawing, specifications and contractual requirements
- Be responsible for analyzing the needs of training according to the survey, employee development and business needs
- Leads a team in handling a Continuous Improvement Project (Mile Deep and Mile Wide) using a problem solving methodology
10
Skills For Principle Engineer Quality Resume
- Works cross-functionally (EM’s, engineering, clinical/medical) in identifying and resolving issues
- Performs quality audits, including supporting International Standards Organization (ISO) audits, and maintains quality manual
- Knowledge of manufacturing, welding, paint and assembly
- Knowledge of ISO quality standards, best-in-class quality control and improvement tools. Working knowledge of Lean Manufacturing and Six Sigma techniques
- Leads in resolving customer quality issues and driving root cause and corrective action on process and product quality issues
- Assists in developing and deploying SPC initiatives
- Uses quality tools consistent with quality processes to enable the focus on prevention by identifying and performing activities to minimize risk
- Thorough knowledge of quality engineering techniques for FMEA (Failure Mode Effect Analysis) & problem solving such as 8D Concern Analysis
List of Typical Responsibilities For an Engineer, Quality Resume
1
Responsibilities For Engineer Quality Resume
- Participate in problem solving activities related to design, manufacture, inspection, and test, including CAPA, NCR and supplier related issues
- Engages in applying/leading Quality tools on Customer Support Process CSP, Continuous Improvement CI ,and/or Value Improvement VI teams
- Responsible for establishing the internal auditing plan each year
- Drive and monitor change management process to ensure thorough completion of all changes resulting in timely closure of change requests
- Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, sub assemblies and contract processing
- Develop and lead training for CAPA, RFA, and ICS systems
- Process requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals
- Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction and mitigation
- Familiarity with ISO 13485, GDP, GMP concept desirable
2
Responsibilities For Principal Engineer, Quality Resume
- Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment
- Knowledge of Risk Based and statistical concepts desirable
- Accepts change openly and adopts a continuous improvement orientation to the role
- Investigate and resolve client’s complaints that occur in product quality
- Co-ordinate first article and product qualification of new and modified
- Process error prevention methodology such as FMEA’s
- Review and approve design and process changes for measurability, consistency and impact on products, processes or other areas and recommend changes
3
Responsibilities For Engineer, Quality Senior Resume
- 5s, safety concept, regular summary & review
- Self-management ability with high efficient approaches
- Be familiar with TS16949 and AutoCAD
- Maintain up to date knowledge of Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR), MDD 93/42 EEC and other applicable international medical device standards and regulations
- Solve identified issues through analysis, critical thought, and development of a clear set of recommendations to the team and management for resolution
- Participates in in the improvement of product and manufacturing quality and reliability through tools appropriate for the project, such as test sample size selection, test method validations, Gage R&R studies, and SPC
- Contribute as part of multi-departmental teams in product and process risk analysis and risk management activities, including the development of product and process FEMA and Risk Analysis reports
- Ensures robust application of the quality system by supporting the entire Quality Management System including the CAPA, NCR, customer feedback activities, and product failure analysis
- Develop and maintain Design History Files (DHF) for products
4
Responsibilities For Product Reliability Engineer Quality Resume
- Review procedures, process sheets, PMI’s, Eng. Changes when required, and approve as necessary
- Establish and execute the proactive quality efforts in cooperation with CSM, SSB, and Rockwell Automation’s Quality function
- Contribute the development and utilization of CSM’s and SSB’s quality tools. Coordinate all process improvement activities directed by the Company’s Quality function. Identify process gaps and improvement opportunities. Focus on identifying and executing mistake-proof solutions for any systemic improvement opportunities
- Lead global quality activities including War Room meetings on a monthly basis and drive process/tool standardization for CSM and SSB. Support the communication of CSM’s and SSB’s quality metrics and improvement actions, collaborating with the cross-functional global organization
- Participate in and provide quality support in problem solving efforts to identify and resolve quality issues to ensure production of safe and effective medical devices
- Experience with Design Controls/Design Verification with electro-mechanical AND software focus
- Experience in Related Filed
5
Responsibilities For Industrial Engineer / Quality Resume
- Recommend, plan and lead corrective and preventive actions for continuous improvements including investigations and root cause analysis
- Lead and work with teams to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives
- Generate quality reports, evaluate and trend quality data, and propose solutions to drive process improvements
- IEC 62304, ISO 13485, FDA standards
- Provide day to day containment of factory quality issues and corrective actions with component suppliers including but not limited to notifying suppliers of non-conformances and processing quality notifications
6
Responsibilities For Project Engineer, Quality Resume
- Provides quality planning, control, and improvement support for product development teams, manufacturing engineering, supply management, and manufacturing and/or distribution organizations to assure product quality meets the customers expectations
- This includes the application of quality tools within the Enterprise Product Delivery Process EPDP Enterprise Order Fulfillment Process EOFP and Customer Support Process CSP
- Ensuring compliance (of products) with legal and normative requirements through proactive risk management and mitigation strategies
- Supports application of quality tools with key suppliers as an integral element of quality planning
- Participates on PDP Product Delivery Process teams as the Quality representative, ensuring quality activities and plans are formulated and followed. Engages in applying/leading Quality tools in Product Delivery Process PDP teams
- Participates in Design Process and Assembly Reviews DPARs, print reviews, and design reviews of new products
- Failure Modes Effects Analysis FMEA
- Executes Quality Control Plan where implemented
- Investigates product quality problems, determines root cause for quality problems, gathers and analyzes data and implements corrective action to reduce or eliminate non-value waste resulting from non-conformances, scrap or reclaim
7
Responsibilities For Improvement Engineer Quality Resume
- Plan and implement LIVE Quality culture within project and organization level (Implement the defined processes, optimize existing processes, initiate process improvements, and drive continuous improvements (CI) in projects)
- Work with internal delivery team and other functions in order to meet the specified success criteria of project
- Collaborate with onsite teams to improve process efficiency
- Drive best practices within the organization
- IATF 16949; VDA, APQP, MSA, SPC knowledge
- Drive continuous improvement across facility’s Key Process Indicators (scrap, rework, PPM) utilizing Lean, Six Sigma, Poke Yoke and related process improvement tools and methodologies
8
Responsibilities For External Engineer, Quality Resume
- Key member of the Quality Team – Provides specific guidance and direction to general staff as well as department managers, functional owners in implementation of the quality system and compliance with quality standards and regulations
- Monitor and follow-up on supplier quality and corrective actions as necessary
- Monitor MRB along with timely disposition of suspect product
- Provides quality engineering expertise in the areas of Design Controls, Risk Management, Quality Assurance/Control, Regulatory Compliance, and Statistical Techniques
- Provides quality engineering support for new indication projects to support regulatory submissions, clinical trials, and ensure compliance to design control requirements by approving design control documentations
- Ensures that appropriate Risk management systems and programs are in place and effective
- Assists risk management activities including design and use FMEAs creation
- Assists design verification activities for real time aging project
- Collaborates with a cross functional team to help facilitate the successful execution of the new product development/indication expansion projects and launching of robust products
9
Responsibilities For Lead Engineer Quality Resume
- Ensures compliance with all Federal, State, local and company regulations, policies and procedures
- Maintains an up to date knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques
- Maintains an up to date knowledge of the company products, policies, and procedures
- Lead complaint investigations on returned product. Manage corrective action and quality improvement activities
- Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics
- Responsible to collect data for the department, create daily, weekly, monthly and quarterly metrics
- Perform system and component defect analysis in conjunction with the continuous improvement program
- Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action), Internal Customer Signals (ICS), and product Requests for Analysis (RFA)
10
Responsibilities For Principle Engineer Quality Resume
- Works with key stakeholders to develop and maintain procedures and forms for the CAPA, product RFA, and ICS systems
- Guide Quality Engineers and Supplier Quality Engineers with product review and analysis for CAPA, ICS, and RFA activities
- Maintain databases and record storage for CAPA, RFA, and ICS systems
- Lead meetings and communications for CAPA, RFA, and ICS system information, concerns, and updates
- Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues
- Seeks out information independently and able mentor/coach other members of the organization on CAPA, ICS, and RFA practices
- Present CAPA, ICS, and RFA System to internal and external auditors. Investigate and resolve system nonconformances and concerns (defined during internal and external audits)
- Working with Process Engineering and Operations in PDP & PTP Process
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