Senior Engineer, Quality Resume Sample
Karianne Zemlak
4752 Eloisa Ville,
Boston,
MA
+1 (555) 394 6356
Work Experience
Senior Engineer, Quality
06/2016
-
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
- CQE or equivalent course work / experience desirable
- Proficient in understanding of Med Device manufacturing processes desirable
- Familiarity with ISO 13485, GDP, GMP desirable
- Lean Six Sigma training a distinct advantage
- Have a good understanding of engineering and quality practices & methods
- Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs
Senior Engineer Quality
08/2013
-
02/2016
Philadelphia, PA
- Highly developed problem solving and strong analytical skills
- Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
- Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes
- Manages change well and adopts a continuous improvement orientation to the role
- Excellent English (both oral and written)
- Be the voice of Quality when dealing cross functionally
- Maintains / enhances the ISO 9000 Quality System, develops procedures and forms, performs failure analysis, dispositions product, resolves quality issues and develops corrective actions
Education
Whitworth University
2008 - 2013
Engineer's Degree in Engineering
Professional Skills
- Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills
- Excellent communication, problem solving, influencing, and time management skills
- Strong statistical analysis, knowledge of sampling plans and root cause investigative skills
- + Demonstrated analytical skills to proactively identify and solve problems
- Strong communication and interpersonal skills with ability to work well in high pressure environment
- Proven ability to demonstrate analytical capabilities (including designing and executing DOE’s, statistical analysis, analytical design tools etc.)
- Proficient computer skills including familiarity with word processing programs, spreadsheets, and graphics
How to write Senior Engineer, Quality Resume
Senior Engineer, Quality role is responsible for software, training, integration, database, auditing, security, reporting, manufacturing, design, assembly.
To write great resume for senior engineer, quality job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Engineer, Quality Resume
The section contact information is important in your senior 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 Senior Engineer, Quality Resume
The section work experience is an essential part of your senior 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 senior 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 senior engineer, quality position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Engineer, Quality resume experience can include:
- Develops procedures and forms, performs failure analysis, dispositions product, resolves quality issues and develops corrective actions; revises processes and procedures to help evolve the Quality System
- Provides support for existing products; this involves the disposition of problem reports, working with suppliers, evaluation of customer complaints, review and approval of drawing changes, and development of QAPs
- Excellent verbal and written communication skills. Italian mother tongue and fluent English
- Strong verbal and written communication skills with a customer-oriented approach
- Demonstrated analytical skills to proactively identify and solve problems
- Develop and execute streamlined business systems which effectively identify and resolve quality issues
Education on a Senior Engineer, Quality Resume
Make sure to make education a priority on your senior 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 senior 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 Senior Engineer, Quality Resume
When listing skills on your senior 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 senior engineer, quality skills:
- + Effective interpersonal, verbal and written communication skills to drive tasks to completion
- Manage a varied workload and prioritize effectively
- Superior technical writing and problem solving skills required
- Operates within established budgets by developing cost effective methods to improve quality
- + Operates within established budgets by developing cost effective methods to improve quality
- Experience with CADENCE, Altassian Suite -JIRA / Confluence, and Solid Works valued
List of Typical Experience For a Senior Engineer, Quality Resume
1
Experience For Senior Engineer Quality Resume
- Effectively present information and respond to questions from groups of managers and / or engineers
- Train on the use of barcoding
- Investigate, identify, and implement best-in-class Quality Engineering practices
- Complete complaint investigation activities and coordinate reporting of results and trends
- Participate in developing team settings, as assigned
- Assist with MDR & Vigilance reporting to appropriate regulatory officials
- Conduct specialty testing for shape-memory Nitinol material
- + Establishes the quality requirement, assuring that delivered products/components meet the design and reliability requirements
2
Experience For Senior Engineer, Quality & Reliability Resume
- + Approves manufacturing processes, test instructions and specifications for conformance to program quality requirements
- + Performs Quality audits on various processes to ensure that all requirements are being followed
- Read and interpret engineering piece part and assembly drawings and specifications
- Develop Quality Engineering deliverables in compliance with applicable standards
- Maintain current knowledge of federal, state, and international regulations regarding safety agency, GMP, ISO, MDD, and quality assurance
- Participate in audits including internal, FDA and Notified Body
- Performs in-house calibration of tools
- Create Visual Workmanship Standards for inspection
- Support all interactions with Customer and Government Representatives
3
Experience For Senior Engineer, Quality Resume
- Support Continuous Improvement activities for assigned Program(s)
- Visit suppliers to review product & process issues
- Oversee all quality related issues for assigned Program(s) and serve as Material Review Board (MRB) & Corrective Action Board Chairperson
- Release product for distribution
- Participate in external Quality System audits
- Coordinate and report on the product complaint system
- Evaluate non-conformances and implement appropriate corrective actions
4
Experience For Senior Engineer Quality Resume
- Coordinate calibration activities of Quality System
- Conduct work in and maintain a clean, safe, health conscious work area
- Conduct other tasks and responsibilities, as requested
- Support PDP process for new Products
- Lead/Support investigation by conducting problem solving and root cause analysis to address failures identified by customer complaints, internal non-conformance’s and manufacturing yields
- Lead/Support CAPAs and QIA’s to ensure effective closure of all actions as per the plan
5
Experience For Senior Engineer, Quality & Reliability Resume
- Lead/Support accurate and timely review of Device History Records (DHR’s)
- Support in collating & responding to assigned customer quality audit questionnaires & requests, follow-up with customers’ issues, follow-up/closure, and the planning, and coordinating customer audits
- Lead / Support investigations by conducting problem solving and root cause analysis to address failures identified by customer complaints, internal non-conformance’s and manufacturing yields
- Lead / Support validation activities and effective closures of CAPA’s QIA’s as per the agreed timeline
- Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s
6
Experience For Senior Engineer, Quality Resume
- + Performs complex quality assurance tests and inspection activities
- + Initiates and leads root cause analysis for process related concerns, analyzes process audit results, and recommends proper corrective and preventive action
- + Provides significant expertise and knowledge on complex issues and acts as a professional resource for colleagues
- + Other responsibilities as assigned
- + Consistent exercise of independent judgment and discretion in matters of significance
- Uses statistical techniques such as DOE, SPC, Gage R&R, capability studies and Six Sigma to improve designs, analyze problems and monitor processes
- Performs failure analysis, resolves quality issues and develops corrective actions
- Provides support for existing products; this involves the disposition of problem reports, working with engineering, evaluation of customer complaints, and review and approval of drawings and changes. Generates reports summarizing test results, and trend analysis of data
7
Experience For Senior Engineer Quality Resume
- Active participant in the PAC / APQP process
- Certification in Cause and Effect Analysis
- Provide input from concept to production on all quality related issues
- Participate in Regulatory activities as required
- Performs complex quality assurance tests and inspection activities
8
Experience For Senior Engineer, Quality & Reliability Resume
- Initiates and leads root cause analysis for process related concerns, analyzes process audit results, and recommends proper corrective and preventive action
- Provides significant expertise and knowledge on complex issues and acts as a professional resource for colleagues
- Maintains confidential information as such
- Consultant/Division expert; Division Technical expert
- Develops Innovative ideas for the organization
- Influences and directs others across organization; Coach/Mentor
9
Experience For Senior Engineer, Quality Resume
- Participates and leads cross-functional teams and/or projects
- Provides technical support on components, material methods, systems, processes and/or equipment
- Writes and approves protocols, reports and data
- Conducts and/or supports product complaint investigations
- Analyzes problems in design, process, and/or test development. Recommend/implement solutions
- Develops and implements procedures/policy
- Support First Article Inspections
10
Experience For Senior Engineer Quality Resume
- Continuously improve the quality system and ensure alignment to the global BMS quality management system. Maintain certification and relevant procedures in the BMS
- Manage Quality Change Requests and maintain Axapta. Drive on time data registration through the relevant production and quality employees
- Management BU system documents and blade package records
- Complete local quality reports, regional reports & BOR report
- Review quality performance regularly. Highlight issues and push for improvements and solutions
- Translate quality changes, inform the relevant departments and track the performance
- Lead the internal quality audit in plant
- Lead the internal firewall inspection in plant
- Participate in the internal Global audit; prepare for MFG process audit, FAI audit, particular MFG audit, external customer audit and third party audit
List of Typical Skills For a Senior Engineer, Quality Resume
1
Skills For Senior Engineer Quality Resume
- Demonstrated knowledge with medical device regulations and experience with FDA regulatory standards and ISO13485
- Perform sterilization validation/re-validation activities & processes
- Computer skills (Word, Excel, and PowerPoint) required
- Experience in Automotive Quality, along with development & testing is
- Extensive knowledge and experience in device development and manufacturing, from concept to release and distribution
- Drive the implementation of corrective and preventive actions through the CAPA owner and ensure effective tracking
2
Skills For Senior Engineer, Quality & Reliability Resume
- Is capable and willing to have effective customer and supplier interactions and/or frequent inter-organization contacts
- Masters of Science, Engineering or related subject with 0 years of experience
- Experience working in a regulated medical device environment
- Act as an effective leader/team member in supporting quality disciplines, decisions, and practices
- Strong working knowledge with Minitab and Capability Analysis (Six Sigma)
- >6 years of work experience with sufficient exposure to medical device or related industries
- Development Experience in C++, JAVA
3
Skills For Senior Engineer, Quality Resume
- Strong competency in Bayer’s Core Competencies: Customer Focus, Drives Results, Instills Trust and Manages Complexity
- Direct experience within the medical device industry (FDA Regulated)
- Experience and recognized as an expert within a technical discipline
- Demonstrated initiative and sound judgment
- Experience in Quality Management
- Show good capacity for attention to detail
4
Skills For Senior Engineer Quality Resume
- Extensive experience with electronic design, electronic components and their manufacture
- Manages/develops validation studies on equipment & processes
- Drive Engagement and Builds effective teams
- Experience with root cause analysis and problem solving techniques
- Knowledge and experience in root cause analysis
- Conduct qualification, verification, and validation activities
- Years of work experience
- Research non-conforming material, reviewing dock-to-stock status and adjusting as required, initiating product recalls when necessary, and leading meetings
5
Skills For Senior Engineer, Quality & Reliability Resume
- Manages project planning, budgeting, scheduling and tracking
- Initiative and self-direction in planning, organizing, documenting and solving problems
- Position requires remaining stationary as well as standing and walking for extended periods of time
- Develops manufacturing process flowcharts, including defining people and material flow issues
- Follow up corrective actions from customer feedback, CAR’s from Quality System audits and Quality problems detected during manufacturing
- Provide support to engineering groups in the setting up quality tools, metrics, processes
6
Skills For Senior Engineer, Quality Resume
- Provide training/coaching on quality related issues to Ferdinand production associates and management
- Prepares periodic reports, analyzing data and extracting negative trends that require attention or preventative action. Coordinates related actions
- Maintain documentation and records resulting from quality management system activities and according to established procedures
- Develop and document all Visual Planning/Electronic Planning Inspection Instructions for hardware and materials associated with assigned Programs
- Provide a leadership role in championing departmental or cross-functional engineering initiatives
- Supervise manufacturing inspections and auditing
- Supplier Quality Engineering – Vendor Qualification and performance monitoring
- Partners with Engineering and Product Management while maintaining independence
7
Skills For Senior Engineer Quality Resume
- + Advanced knowledge of Quality Engineering processes and regulatory requirements
- + Ability to improve products or services by applying professional and business knowledge
- Expert in Code Reviews and Unit Testing
- Interacts with Group Leaders, Team Leaders, and Engineering in the identification and resolution of product quality problems
- Support the Ferdinand Quality System by performing tasks to ensure compliance and initiate continuous improvement of the system
- Generate, modify, and complete Standard Operating Sheets (SOS)
8
Skills For Senior Engineer, Quality & Reliability Resume
- Report out on projects using the A3 project management process / format
- Desire to continually learn in to keep up with changing technology
- Background in electronic planning and data collection systems
- Establishes the quality requirement, assuring that delivered products/components meet the design and reliability requirements
- Approves manufacturing processes, test instructions and specifications for conformance to program quality requirements
9
Skills For Senior Engineer, Quality Resume
- Performs Quality audits on various processes to ensure that all requirements are being followed
- Broad business and technical understanding
- Critical Decision Maker in areas of engineering and business needs.Project Leader; Representative of BAS
- Manages testing outlined in protocols and test methods
- Systematically manage multiple projects from initiation through closing phases. Projects include BAS and/or supplier resourced deliverables
- Proficient in risk management practices and tools, having high expertise in process risk
- Proficiency in and makes continuous strides towards optimization of inspection methods and sampling
10
Skills For Senior Engineer Quality Resume
- Create new and modify existing plant documents and procedures related to the quality system
- Lead the site readiness program for external audits and inspections. Support the site Quality Manager during external/regulatory inspections/audit management
- Have oversight on the site regulatory compliance, including follow up to regulatory commitments
- Ensure fulfillment of compliance training requirements per established schedule
- Performs Internal Quality Audits and in-process and receiving inspection as required
- Generates reports summarizing test results, and trend analysis of data
- Performs training on Quality Systems
- Setup data collections within Maestro (Oracle) and Delmia/Electronic Planning
List of Typical Responsibilities For a Senior Engineer, Quality Resume
1
Responsibilities For Senior Engineer Quality Resume
- Leads six sigma improvement projects and maintain related documentation. Devises new approaches to problems. Works on complex problems where analysis of situations or data requires in-depth evaluation of various factors. Acts as a key contributor and/or technical leader within a project team
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into product. Devises methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and product equipment, participating to team activities on tools like FMEA, Dynamic Control Plan
- Assists for problems related to materials and interface with SQE. Specifies and/or assesses inspection and testing mechanisms and equipment e.g. through Gage R&R statistical studies
- Prepare or evaluate reports of statistical analysis (e.g. Cpk process capability) to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications
- Participates to definition of engineering changes and temporary deviations (needed tasks and roles), ensuring the integrity of Customer specifications and expectations and the product reliability
- Proficient experience with automotive SPICE
2
Responsibilities For Senior Engineer, Quality & Reliability Resume
- Proficient experience with methods for problem and risk analysis
- Planning, realization and monitoring of the process and quality activities for the Car Powertrain Technology team in UK
- Local customer contact for engineering processes and engineering quality
- Variation removal: by removing sources of variation, we achieve standardization and efficiency; we allow reliable planning and delivery as per expectations
- Assurance of project related engineering quality
3
Responsibilities For Senior Engineer, Quality Resume
- Advanced knowledge of Quality Engineering processes and regulatory requirements
- Improve products or services by applying professional and business knowledge
- Lead cross-functional initiatives with measurable results
- Quality Technician, coordination, development, and supervision. For the team on Shift A,B and C. The team constitute of 11 QC
- Decision Quality / Plans and aligns
- Persuades and manages ambiguity
- Define and execute the Quality plan in accordance with organizational BMS and ASPICE
4
Responsibilities For Senior Engineer Quality Resume
- Initiate and complete Quality Investigations to identify root cause and implement effective solutions (corrective and preventive actions) for product/process quality issues, corporate/external audit observations and quality system compliance issues as required
- Utilize technical background (including statistical knowledge and root cause analysis tools) to assist in data collection, analysis and reporting associated to process improvement but also as input to management for decision making
- Actively participates in preventive/proactive quality and operations improvement projects
- Provide inputs to the US Region Service Quality Management Review and Operational Review meetings
- Support site readiness activities associated to external audits and regulatory inspections
5
Responsibilities For Senior Engineer, Quality & Reliability Resume
- Oversight and drive improvements to meet established quality objectives and performance indicators goals associated to tasks under responsibility
- Provide support to initiate Change Request packages for Quality System procedure changes
- Superior written and verbal communication skills, capable of synthesizing a problem statement/situation/observation and providing a concise synopsis to upper management
- Coordination of organizational Quality Management for local product development
- Provision of process and quality trainings for the local development engineers
- Interface with cross-functional teams, all levels of personnel and management
- American Society for Quality Certified Engineer (CQE) highly desirable
6
Responsibilities For Senior Engineer, Quality Resume
- Proven ability to demonstrate technical and analytical capabilities (including designing and executing DOE’s, statistical analysis, analytical design tools, IEC 60601-1 etc.)
- Related quality engineering experience
- Knowledge in continuous improvement methodologies
- Focused to team work
- Read, analyze, and interpret engineering drawings and specifications, general business periodicals, professional journals, technical procedures, or governmental regulations
- Write reports, specifications, business correspondence, and procedure manuals in English
- Clearly and concisely convey project accomplishments, obstacles, issues, and project status
7
Responsibilities For Senior Engineer Quality Resume
- IT-I (SSBI) Favorable Background Investigation
- IAT II Certification Required at Start (CCNA Security, CSA +, GICSP, GSEC, Security + CE, or SSCP)
- MCSA Certification required within 6 months of hire
- Basic knowledge of product design and process development
- Diagnose problems and recommend solutions in assigned area
- Interpret and adapt internal guidelines
- Exude a passion for new technology development
8
Responsibilities For Senior Engineer, Quality & Reliability Resume
- Use of hands and fingers to manipulate office equipment is required
- Knowledge of ISO and FDA/QSR requirements and system development & management in medical device industry
- Capacity for innovation and ability to work on own initiative
- Thorough knowledge of management systems, at least one of CMMi or Automotive
- Quality Engineering experience or equivalent education / experience, with at least 1 year experience within medical device industry or other regulated manufacturing environment (i.e., biotech, pharma, aerospace)
- Conduct statistical, geometric, and mathematical calculations
- Conduct responsibilities substantially free from routine supervision
- Preferably in a STEM discipline
- Typically requires travel less than 5-10% of the time
9
Responsibilities For Senior Engineer, Quality Resume
- Continuous improvement: products or processes can always be made better. Working in the lab, on the production line, in the meeting room with the concerned people. Providing innovative resolutions to a diverse range of complex problems
- Drive relevant KPIs
- Basic quality tools
- Committed to work
- Up to 20 %
10
Responsibilities For Senior Engineer Quality Resume
- Work with mathematical concepts such as probability and statistical inference; perform statistical and graphical analysis of data
- Able to solve complex problems; makes decisions based on the analysis of multiple sources of information
- Apply and interpret statistical data
- Actively participates in the Layered Process Audit to resolve those problems
- Interacts with internal and external customers to resolve quality problems
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