Staff Quality Engineer Resume Sample
Deondre Halvorson
411 Charlotte Ramp,
San Francisco,
CA
+1 (555) 137 8640
Work Experience
Senior Staff Quality Engineer
09/2017
-
PRESENT
New York, NY
- Experience applying quality regulations and standards (21CFR 820, ISO13485) and establishing quality systems
- Experience in QC testing, data review, and product release
- Experience in change control and failure investigation
- Applied experience with quality and statistical tools (SPC, 6 sigma, Risk Analysis, FMEA, Trend Analysis)
- Excellent attention to detail, well organized and able to work independently and as a team
- Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work
- In depth working knowledge of FDA and EU device regulations
Staff Quality Engineer
07/2012
-
04/2017
San Francisco, CA
- Proven track record in developing design and validation and verification protocols, process validation, product inspection and test methods
- Extensive experience in CAPA, internal audit, complaints, and validation processes
- Experience and basic understanding of statistics and the application of statistics in data analysis and trending
- Direct experience in leading, performing and documenting quality audits against the following standards: 21CFR820, 11, 803, 806, GMPs, ISO 13485, and ISO 9001
- Experience in the integration of quality system requirements into business processes
- Root cause analysis expertise
- Adapt quickly to change and work in a rapidly changing environment
- High level of organization, self-motivated, and proactive
- Perform at the highest level in fast-paced environment
Staff Quality Engineer Quality LCM
02/2009
-
06/2012
Los Angeles, CA
- Develops, implements, and maintains new Advanced Product Quality Planning (APQP) processes and revises existing APQP Plans across multiple product lines incorporating benchmark and standardized processes across the Company while ensuring flawless product quality measures are instituted
- Is the Lead Quality Expert as member of New Product Development Team(s) to assure development and execution of Quality Plans as critical subset of Product Development Plans
- Trains and Coaches others in APQP techniques and in the use of scientific approaches including statistical tools
- Audits APQP plans for compliance
- Travels as need to NPD team meetings and to support Supplier Engineers, Supplier Development Activities and to help develop and oversee their implementation of effective corrective action plans
- Identify Critical Quality Attributes and identifies the most effective steps to ensure these attributes are controlled (though inspection, process selection, etc)
- Subject matter expert in risk management practices and concepts. Organize medical risk management boards
Education
Missouri University of Science and Technology
2004 - 2009
Engineer's Degree in Engineering
Professional Skills
- Leadership: Possess demonstrable leadership skills; has the ability to move others to action, including peers, superiors and subordinates. Demonstrate a positive, results-oriented style. Able to develop others, and manage performance of team through coaching and feedback, willing/able to share personal knowledge and experience with others
- Communication Ability: Ability to develop and articulate an effective flow of ideas and information that generates understanding and creates a climate in which others are informed and want to participate. Communicates complex concepts into everyday language
- Courage: Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Is looked at for direction in a crisis. Willing to try new ways without fear of failure. Challenges the status quo. Takes stands to resolve important issues. Energized by tough challenges. Is comfortable with change
- Organizational Agility: Able to foster excellent relationships and credibility quickly at all levels of the organization. An ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives. Can see and understand what drives policies, practices, and procedures
- Customer & Patient Focus: This individual needs to understand company’s customers and competition to maximize opportunities and advantages, and search for ways to leverage the company’s current position. Advocates for patient safety and health above all else
- Results Focused: A confident individual who provides a good balance of risk taking and sound judgment in order to deliver optimal results. Is able to drive goal attainment in others with energy and focus
- Excellent skills in analytical thinking, problem solving, written and oral communication skills
How to write Staff Quality Engineer Resume
Staff Quality Engineer role is responsible for engineering, analytical, design, analysis, leadership, interpersonal, technical, development, manufacturing, organizational.
To write great resume for staff quality engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Staff Quality Engineer Resume
The section contact information is important in your staff quality engineer 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 Staff Quality Engineer Resume
The section work experience is an essential part of your staff quality engineer 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 staff quality engineer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular staff quality engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Staff Quality Engineer resume experience can include:
- Demonstrated leadership and organizational skills with a proven track record of accomplishments in cross-functional projects/teams/programs
- Excellent technical writing skills with the ability to summarize data and descriptions of events or investigative work into reports and presentations
- Negotiating, facilitating and leadership skills
- Manufacturing equipment Software validations/Computer system validations
- Experience building and executing automated scripts or experience with other open source automation tools
- Prior hands on experience with VMware’s vSphere Product line, especially in the areas of Networking, is highly desirable
Education on a Staff Quality Engineer Resume
Make sure to make education a priority on your staff quality engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your staff quality engineer 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 Staff Quality Engineer Resume
When listing skills on your staff quality engineer 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 staff quality engineer skills:
- Excellent interpersonal relationship skills including negotiating and relationship management skills
- Excellent demonstrated skills in analytical thinking and problem solving
- Excellent verbal and written documentation skills, strong attention to detail, ability to work directly with design engineers and manufacturing personnel
- Quality engineering experience with demonstrated ability to assume increasing responsibility, or equivalent level of experience
- Excellent skills in analytical thinking and problem solving
- Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication
List of Typical Experience For a Staff Quality Engineer Resume
1
Experience For Senior Staff Quality Engineer Resume
- Effectively prioritize and manage multiple activities and responsibilities is required
- Proven leadership skills and expereince
- Excellent both written and spoken communication skills in English
- Process Capability experience and Process Validation experience is required
- Results orientation with strong written and oral communications skills to lead cross-functional teams
2
Experience For Staff Quality Engineer, Advanced Resume
- Strong Project Management skills and ability to influence peers and management
- Experience with human factors and clinical design validation required
- Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets is required
- Prior experience with Regulated software development
- Related work experience, or demonstrated performance
- Drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
- Experience with process validations and the use/application of statistical tools is required
- Prior experience with statistical software is required
- Contributing to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions
3
Experience For Staff Quality Engineer Quality LCM Resume
- Support manufacturing and quality process improvement projects as an effective team member or leader using continuous improvement and six sigma tools
- Skill with project planning and execution
- Excellent process thinking
- New product development experience is required
- Owning QMS Value Added Services integration including assuring correct and timely closure of projects
- Running and monitoring of improvement programs with suppliers on basis of assessment and root cause analysis results
- Manufacturing Quality Plan Activities
4
Experience For Product Software Staff Quality Engineer Resume
- Working knowledgeable of ISO 9001:2008, ISO 13485:2003 and 21 CFR Part 820
- Working Knowledge for Functional Safety Standards, ISO26262, IEC61508, and DO254 as applied to FPGA
- Leading change across organization and businesses
- Understanding of IEC-60601, IEC-62366 and IEC-60950 (Desired)
- Assist with drafting, reviewing and approving Non-Conforming Material Reports
- Provide local quality engineering project support, including but not limited to continuous improvement and sustaining engineering projects
5
Experience For Staff Quality Engineer, Apqp Resume
- Proficient in process auditing with significant competency in analyzing. troubleshooting and resolving complex quality situations
- Provide manufacturing line support, including but not limited to deviations, non-conforming product, complaint investigations and failure investigations
- Provide support and expertise in developing and executing a reliability strategy during new product development
- Is a team member representing Quality on new product development and sustaining engineering projects
- Listen to others; including associates, managers, peers and customers when making decisions and solving problems
- In electronic systems manufacturing or equivalent industries in manufacturing and quality engineering roles
- Broad technical knowledge including: Operating system fundamentals (task scheduling, memory management)
- Provides mentoring / coaching for application of technical principles, theories, concepts and quality, tools and systems
- Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work
6
Experience For Associate Staff Quality Engineer, QMS Resume
- Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products
- Deep understanding of theoretical and practical fundamentals and experimental engineering techniques
- Division Process owner for NC/CAPA working with Corporate and the manufacturing facilities
- Develop & deliver training and coaching for new CAPA users on CAPA principles and on the system
- Advanced knowledge of Quality Engineering/Scientific methods and techniques. Applied statistics of increasing complexity is required
- Responsible for communicating and working with Suppliers in regards to Quality issues
- Responsible for revising and creating Buy Specifications
- Provide sampling plans and approve inspection, methods for evaluation and testing of components and products
- Provides training for operations and engineering teams on best practices
7
Experience For R&D Associate Staff Quality Engineer Resume
- Provides mentoring and coaching for application of technical principles, theories, concepts and quality, tools and systems
- Ensures that the quality aspects for new processes, products and or upgrading of existing processes and products and subsequent PQ’s are met
- Support new product introduction and investigation activities including review of PFMEA and initial control plans, including participation in APQP and NPI
- Provide QA technical and compliance expertise as part of development teams in establishing and assuring product quality objectives
- Quality activities in a manufacturing environment including quality systems improvement, documentation of quality requirements
- Exposure to commercial considerations including licensing and SLA’S with cloud service providers
- Business acumen to build compelling cases highlighting impact, benefits, and risks for various solutions
- Typical sheet metal and electro-mechanical assembly manufacturing environments. Working environment requires safety shoes and glasses
8
Experience For Staff Quality Engineer, Capa & NCR Resume
- Collaborate with project team to attain shared objectives. Work through difficult decisions requiring a balancing of many factors
- Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
- Assist in meeting plant team plans for cost and quality improvement, operating within department budget guidelines
- Focuses on improving processes that support the Business and Quality Objectives
- Identify opportunities for re-design / design of highly complex equipment, tools, fixtures, etc. to improve manufacturing processes and reduce waste
9
Experience For Technical Staff, Quality Engineer Resume
- Liaison between manufacturing sites, suppliers, new product development R&D, regulatory affairs, and corporate / divisional functions
- Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context
- Ensure appropriate supplier quality management programs are in place for critical materials/components/products, including Quality agreements where applicable
- Support OEM relationships and Quality Engineering activities related to OEM suppliers
- Lead or support Risk Management (in accordance with ISO14971). Evaluation of current products, as well as, new products being developed
- Responsible for WHC Design History Files that reside in Durham, including file creation and maintenance
- Directs and allocates QA resources for WHC sustaining projects
10
Experience For Staff Quality Engineer, D Printed Products Resume
- Quality Lead to assist R&D and manufacturing in development of quality control plans and assessment of supplier's ability to meet designated specifications
- Assists in developing preventive measures to increase product reliability and reduce production downtime
- Leads investigation efforts and accurately documents investigation plans, supporting data, and conclusions. Leads corrective and preventive action projects
- Unit Quality Independent Reviewer During Design Reviews
- Proper Use of Statistics (Sampling Plans)
- Liaise with Manufacturing Plants
- Function as a quality lead on multi-functional product development teams in matters related to Quality Engineering
- Responsible for developing comprehensive quality strategies
- Lead the development of comprehensive risk documentation for the product and process, including overall risk management plans and reports
List of Typical Skills For a Staff Quality Engineer Resume
1
Skills For Senior Staff Quality Engineer Resume
- Strong communications skills in working with non-native English speakers
- Excellent communication, problem solving, organizational and interpersonal skills are required
- Demonstrated Project Management skills, such as supporting multiple projects simultaneously is required
- Strong technical engineering skills. Able to understand drawings and device design at a practical level
- Excellent German and English skills complete your profile
- Prior experience with reliability engineering testing (Desired)
- Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software are required
- Problem solving and Credo-based decision-making skills
- Demonstrated hands on experience in supporting processes, tooling and materials used in the industry
2
Skills For Staff Quality Engineer, Advanced Resume
- Partner with R&D Engineers to develop/perform design verification/validation testing, including test method development/validation activities
- Demonstrated experience with continuous improvement projects and leading teams
- Exceptional organizational and tracking skills
- Strong understanding of Product and Global Product and Non-Product Software Validation
- Good Manufacturing Practices And Good Documentation Practices
- Use DMAIC (Define Measure Analyze Improve Control) process and skills to diagnose and prevent/solve product design and manufacturing process issues
- Experience, medical device strongly prefered
- Understanding of continuous improvement methodologies including Six Sigma, Lean and Validation
3
Skills For Staff Quality Engineer Quality LCM Resume
- Training in design of experiments and statistics. Class II / III medical device experience
- Working knowledge of 21 CFR Part 820, ISO 13485, ISO 9001 and familiarity with ISO 14971 is strongly prefrerred
- Strong understanding of networking and Linux operating system
- Experience selecting, recommending and applying appropriate quality tools
- Experience working as a Quality Engineer for reagent and instrument based manufacturing product lines
- Experience in engineering schematic reading and interpretation
- Experience directly interfacing and working with component, raw material and OEM suppliers
4
Skills For Product Software Staff Quality Engineer Resume
- Strong technical understanding of manufacturing equipment and processes is required
- Experience supporting Software related R&D design change efforts through development and/or testing
- Experience testing operating systems and distributed systems
- Effective communication with global executive level teams, influencing executive decisions through presentations and compelling data
- Experience with test automation and knowledge of at least one scripting language and one high level programming language
- Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans and design control
5
Skills For Staff Quality Engineer, Apqp Resume
- Participate in plant CAPA activities, including performing focused audits for effectiveness verification
- Expertise in leading edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms is an asset
- Conduct benchmarking to develop more effective methods for improving quality and compliance
- Meet with Customer Engineering and Incoming Quality organization weekly/as required to set/review priorities
- Experience in a manufacturing and development environment
- Experience in software development, expert level of programming, design, and analysis
6
Skills For Associate Staff Quality Engineer, QMS Resume
- Demonstrate capability to understand component and assembly drawing tolerances
- Demonstrated ability to make critical decisions regarding product quality or quality system compliance
- Proven ability to assess and articulate risk when evaluating a situation
- Experience in engineering role or related occupation
- Participating in a highly skilled technical team in a software orientated product range
- Strong understanding of security and distributed systems concepts
- Experience in drug manufacturing and cGMP
- Experience in software quality assurance activities and conducting software audits/process compliance checks
- Very good understanding of software development life-cycle and development
7
Skills For R&D Associate Staff Quality Engineer Resume
- Proven success in influencing teams as required
- Experience working with cross-functional teams and remote teams
- Good software engineering practices
- Experience in a product development / product engineering environment, with an emphasis on consumer products
- Experience in manufacturing, plastics or automotive industries
- Experience in Java programming with Selenium, JUnit and TestNG
- Solid understanding of SDLC concepts
- Previous experience working with plastics, resins, chemicals, mechanical parts, labels, foams, harnesses, etc
8
Skills For Staff Quality Engineer, Capa & NCR Resume
- Experience with software quality engineering required
- Strong familiarity with TCP/IP protocol suites, VLANS and tunneling
- Experience with IXIA testing equipment
- Strong Knowledge of networking and security concepts
- Good understanding of IO subsystems and virtualization
- Experience in dynamic working environments
9
Skills For Technical Staff, Quality Engineer Resume
- Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives
- Experience leading Quality teams and projects
- Support design and manufacturing test and inspection method development, and lead method validation activities
- Responsible for Incoming Inspection for OEM (Finish Goods) products in the plant
- Previous work experience engaging in a team-based environment is required
- Provide input for business planning, project prioritization and resource requirements
- Advanced experience working with partners / key suppliers / contract manufacturers
- Experience working across sites / within a global company
- Knowledge of validation, equipment calibration, and change control requirements
10
Skills For Staff Quality Engineer, D Printed Products Resume
- Review control plans and gauges for assembly and for improvements. Direct Gauge R&R studies to assure effective gauge implementation and improvement
- Owning QMS Postponement integration including assuring correct and timely closure of projects
- Working understanding of the following standards 60601, 14971, and 62304
- Attending vehicle builds at customer site and provide feedback to the launch team and manufacturing sites to improve manufacturing process
- Understanding of the software development (SW) and testing life cycle as defined by ISO 62304
- Understanding of software issues tracking, automation, risk assessment and bug containment
- Showing initiative in innovative approaches to Quality challenges in a fast-paced, changing global environment
- Working knowledge of statistical methods as well as statistical application software
List of Typical Responsibilities For a Staff Quality Engineer Resume
1
Responsibilities For Senior Staff Quality Engineer Resume
- Review and assess alignment of requirements and frequency between Manufacturer’s Requirements, Operating Guides, Job Plans and maintenance criteria for assigned attractions
- Validation process ownership and site validation compliance according Stryker and ISO/QSR standards
- Review validation protocols for effectiveness and compliance to Corporate Guidelines
- Use the validation system and assist in validations
- Considerable working knowledge in problem solving (8-D methodology), including effective corrective action and verifications of actions
- Lead continuing Test Method Validation and Measurement System Analysis efforts
- Demonstrated application of statistical methods including Design of Experiments, Capability Studies, etc..
2
Responsibilities For Staff Quality Engineer, Advanced Resume
- Experience implementing appropriate risk mitigation with knowledge of product or process and process Risk Management (FDA & ISO standards) is required
- Demonstrated performance with managing cross-departmental projects is required
- A strong background in computer hardware and Intel x86 architecture
- Develop methods to measure, validate and assure quality standards are achieved for applicable product lines
- Maintain documentation for compliance and effectiveness
3
Responsibilities For Staff Quality Engineer Quality LCM Resume
- Effective failure investigation and technical report writing
- Intermediate to advanced experience with word processing and spreadsheets
- Execute and implement effective change control
- Ensure the development and validation of appropriate test methods for product and process techniques
- Experience in quality assurance field, in a regulated environment
- Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE,
- Track record of root cause determination and effective corrective / preventive action implementation
- Test Method Development and Validations
4
Responsibilities For Product Software Staff Quality Engineer Resume
- Process Development and Validation
- Industry experience
- Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO)
- Serve as a multi-functional team member establishing quality requirements and providing guidance for sustaining engineering projects
- Assist with drafting, reviewing and approving Non Conforming Material Reports
- As a developer writing unit tests or Quality/Test Engineer writing automated API-level tests using Java, C#, or C++
- Designs methods for inspecting, testing and evaluating the compliance of development within the process, production equipment and finished products
- Practical working knowledge of Packet Forwarding Data Path in Routers and Switches
- Assist with Complaint Investigations involving the design center and manufacturing sites as necessary
5
Responsibilities For Staff Quality Engineer, Apqp Resume
- Provide mentoring / coaching for application of technical principles, theories, concepts and quality, tools and systems
- Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments
- Interface with Purchasing department in ensuring supplier quality system conformance
- Oversight and activist of NC & CAPA related as an expert and mentor in problem solving and root causing activities
- Risk evaluation of software and firmware within sourcing phase including security and safety requirements
- Assist department and project leaders in developing and reporting appropriate performance and quality metrics
- Cross functional engagement with various VMware’s and partner’s engineering teams and program teams
- Expertise and passion for working with kernel-level and user level code to deliver well integrated solutions
- Lead or support Risk Management (in accordance with ISO14971) evaluation of current products as well new products being developed
6
Responsibilities For Associate Staff Quality Engineer, QMS Resume
- Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results
- Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes
- Support of the following, however are not limited to
- Modify methodologies and procedures, ensuring continuous improvement of desired outcomes
- Position specific responsibilities include support of the following, however are not limited to
- Responsible to implement, revise, execute, and maintain CAPA and NCR procedures including the Stop Shipment process
7
Responsibilities For R&D Associate Staff Quality Engineer Resume
- Responsible for communicating quality and business related issues or opportunities to next management level
- Responsible to comply with all Federal, State, local and company regulations, policies and procedures including Health, Safety and Environmental compliance
- Chair CAPA Review Board as well as corporate trending meetings
- Provide instruction and training to associates on requirements and best practices for CAPA, NCR and Stop Shipment
- Writes and leads risk management activities including risk management reports, hazard analysis, and failure analysis
8
Responsibilities For Staff Quality Engineer, Capa & NCR Resume
- Issue and review supplier questionnaire for adequacy in meeting applicable regulations, standards and requirements
- Primary responsibilities include working in Quality Operations and with other functional groups in support of new product/process development
- Support due diligence and associated activities during mergers and acquisitions
- Post launch monitoring of newly launched product and incorporate lessons learned in future products
- Advanced understanding of quality systems and risk management. Considered the ‘go to’ quality lead on the project
- 3) Provides training for product development teams and continuous improvement team on best practices
- 5) Writes and leads risk management activities including risk management reports and risk analyses
9
Responsibilities For Technical Staff, Quality Engineer Resume
- Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
- Design for Six Sigma training and certification is desired along with knowledge of statistical methodologies
- Work with Regional Complaint Centers to resolve and address complaint handling issues
- Manage all Quality Engineering Deliverables for New Product Development Project
- Proper Use of Statistics (Sampling Plans), Advise on Regulations
- Liaise with Manufacturing Plants, Provide functional support to cross-functional teams
10
Responsibilities For Staff Quality Engineer, D Printed Products Resume
- Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations
- Provides Design Control/ Design Change Control Guidance to product development teams including risk management and support of regulatory strategies and plans
- Identify improvement opportunities and best practices for quality engineering function within BD in response to internal and external drivers
- Provides training for product development teams and continuous improvement teams on best practices
- Collects, interprets and analyzes data and presents to others either orally or in writing
- Work closely with Purchasing on Supplier related activity
- Prepare QA (Quality Assurance) system and assist in technical issues for manufacturing processes that are to be transferred to satellite facilities
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