Staff Engineer, Quality Resume Sample
Lina Ruecker
2888 Courtney Crescent,
New York,
NY
+1 (555) 417 9238
Work Experience
Senior Staff Software Quality Assurance Engineer
08/2017
-
PRESENT
Dallas, TX
- Desk Job/computers, lab work
- Occasionally lift and/or move up to 50 pounds with assistance
- Quality engineer is responsible for auditing design history files (DHF) with new product development teams prior to various design review gates (First in human (FIM), clinical release, commercial release, etc.)
- Own, lead and actively work-on NCRs and CAPAs
- Work on other quality engineering projects as needed
- Perform supplier and internal audits based on the needs of the business. This includes creation of the annual audit schedule, audit agendas, audit execution, drafting audit reports, review and approve audit responses (Investigation, Implementation, Monitoring actions / phase documentation as required
- Assist in generating metrics and identify continuous improvement opportunities
- Note: Require approximately 10% travel
Staff Software Quality Engineer
11/2014
-
06/2017
Dallas, TX
- Demonstrated competency of regulatory requirements such as, FDA QSR’s, ISO 13485:2003, Risk Management (ISO 14971:2012), and Design Controls is required
- Coordinate quality systems and processes to ensure compliance with Quality System and regulatory requirements and promote quality improvements
- Develop and make updates to applicable Site / Unit procedures and policies
- Provides a quality review on a range of quality documentation including Unit Policies, Procedures, Investigations, Change Controls, GMP records and other Quality Management Systems Documentation as required
- Leads unit-level quality system processes and systems (SAP, TrackWise, ECC, DMS, etc) for CAPA, audit, Quality notification, calibration, supplier management, document and change control
- Ensure investigations are conducted and adequately resolved in a timely manner with appropriate CAPAs in place to prevent reoccurrence of issues
- Conducts or leads internal audits and supplier audits
Quality Staff Engineer
02/2012
-
09/2014
Detroit, MI
- Strong knowledge of 21CFR820/210/211/11, ISO 9001, ISO 13485 and other applicable medical device regulations
- Understanding of continuous improvement methodologies including Lean, Six Sigma, SPC, etc. is desired
- Demonstrated ability to support internal / external audits
- Excellent communication, problem solving, organizational and interpersonal skills are essential
- Full proficiency in Microsoft Office required
- Demonstrated ability to work in teams to obtain results is required
- Effective skills in analytical thinking and problem solving required
Education
University of Wisconsin-Richland
2007 - 2012
Engineer's Degree in Engineering
Professional Skills
- Strong skills in Dell Competencies: Driving For Results; Building Effective Teams and Dealing With Ambiguity
- Demonstrated experience prioritizing conflicting demands in a fast paced environment
- Extremely strong communication, facilitation, planning, problem-solving and organizational skills
- Highly developed problem solving and strong analytical skills. Has expertise that is leveraged by the organisation
- Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes
- Demonstrated effective project management skills and collaboration on teams in multiple/global locations is desired
- Solid English written and verbal communication skills. Experience writing detailed technical reports
How to write Staff Engineer, Quality Resume
Staff Engineer, Quality role is responsible for analytical, interpersonal, planning, microsoft, leadership, design, analysis, english, powerpoint, reliability.
To write great resume for staff engineer, quality job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Staff Engineer, Quality Resume
The section contact information is important in your staff 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 Staff Engineer, Quality Resume
The section work experience is an essential part of your staff 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 staff 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 staff engineer, quality position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Staff Engineer, Quality resume experience can include:
- Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
- Strong decision making and problem solving skills based on strong functional and technical knowledge, as well as solid planning and organizational skills
- Strong computer skills (MS Word, MS Excel, MS PowerPoint, MS Project, MS Visio)
- Previous experience with radio frequency (RF) products, wireless devices, or equipment/telecom and/or cellular phone experience are highly desirable
- Communicate effectively and professionally with others inside and outside the company
- Practical experience in design control risk management, validation, change control etc
Education on a Staff Engineer, Quality Resume
Make sure to make education a priority on your staff 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 staff 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 Staff Engineer, Quality Resume
When listing skills on your staff 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 staff engineer, quality skills:
- Manage several projects through the use of excellent analytical skills in planning, organising, and implementing multiple concurrent tasks
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact
- Highly effective communication, facilitation and negotiation skills
- Experience with a proven ability in writing test cases, running functional, or performance tests, and managing defects
- Demonstrated experience and ability to write Java code and/or shell scripts for the purposes of testing solution code (e.g., white-box testing)
- Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands
List of Typical Experience For a Staff Engineer, Quality Resume
1
Experience For Staff Software Quality Engineer Resume
- Working experience with relevant industry standards (ISO13485, ISO14971, IEC62304)
- Read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerance
- Develop good process understanding for systems of record such as SAP, Manufacturing Systems and NC/CAPA/ECI database (EtQ)
- Solid understanding of international and domestic environmental monitoring, sterilization and biocompatibility requirements
- Perform test method validations in support of microbiology operations (e.g. Endotoxin Testing) and interpret the results
- Solid understanding of international and domestic medical device GMPs/ Quality System Requirements
2
Experience For Staff Quality Systems Engineer Resume
- Experience in embedded C programming
- Experience of other programming languages would be an added advantage, like Python,Shell, Perl, etc
- Provide support to software development and testing, software configuration management, software integration and tool validation activities
- Good knowledge of Agile and Scrum methodologies in software development and testing such as BDD
- Review verification and validation reports and identify gaps for GMP compliance
- Ensuring the application of robust testing, risk assessments and subsequent mitigation activities
- Understanding of software as a service delivery and/or web based delivery model
- Responsible for identifying patterns in customer returns and working with engineering teams to implement the actions required to rectify systemic issues
- Lead and support all activities as required to ensure successful transfer of design to manufacturing and responsible for transfer to sustaining engineering
3
Experience For Quality Staff Engineer Resume
- Support Software Development projects, by Reviewing/approving of various product software deliverables, e.g
- Provide ongoing software quality engineering support throughout the software development life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining verification and validation needs and requirements
- Working knowledge of at least one programming environment (e.g. FORTRAN, Visual Basic, C++, MATLAB, and/or R)
- Proficient in understanding of Med Device manufacturing processes required
- Implement/modify quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required
- Manages on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities,
- Guide SW Engineering on the documentation of Unit Testing best practices
4
Experience For Customer Quality Staff Engineer Resume
- Support the development and testing of automated testing frameworks
- Provides strategic and tactical leadership of Quality Engineering Function, based on understanding of 21 CFR Part 820 and ISO Requirements
- A working knowledge of Microsoft office products (MS Word, Excel) and other Testing Software tools is required
- Expertise in reading code and scripting languages
- Capable of building technical credibility quickly with a very broad scientific, medical safety and engineering community
5
Experience For Staff New Product Quality Engineer Resume
- Assertiveness articulating requirements and simplifying systems
- Proficient understanding of Med Device manufacturing processes, FDA QSR, ISO 13485, GMP
- Is considered a subject matter expert for assessing and resolving complex quality issues
- Provide support for software development projects in the manufacturing areas by review/approval of software deliverables
- Serves as a Quality representative on one or more project teams engaged in new product development, manufacturing transfer or other special projects
- Lead efforts in creating harmonized Quality System procedures across sites
- Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization
- Identify and drive opportunities to improve the quality system as it relates to design control deliverables including risk management
6
Experience For Staff Engineer, Advanced Quality Resume
- Report field actions metrics to appropriate review boards such as Management review, CAPA review board, periodic metrics reporting, etc
- Provide instruction and training to associates on requirements and best practices for CAPA
- Review trace matrix to ensure that the mapping is accurate
- Manage onsite and offshore testing resources
- Provide guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance
- Ensure upkeep, assessment and distribution of all regulatory material and ensuring compliance with such documents
- Perform supplier development activities surrounding PPAP
7
Experience For Senior Staff Software Quality Assurance Engineer Resume
- Develop and create procedures for incoming, in-process and final inspection
- Mentorship and coaching others
- Develop test code for , do White Box and Black box Testing to SSD Firmware
- Come up with the test strategy and architecture for automation of functional and non-functional requirements testing
- Own and drive technical design reviews in testing domain
- Part of the agile scrum team, participate in the BDD automation of user stories, in sprint software testing, quality metrics adherence
- Develop and conduct training on software life cycle framework to software developers, testers and other stakeholders within the organization
- Facilitate participation in strategic and technical discussions and risk-based decision making
- Drives measures of accountability through process and motivation; leads by example and mentoring of junior engineers
8
Experience For Staff Design Quality Engineer Resume
- Support post market activities related to product software anomalies - Complaint Handling, MDR’s, CAPAs
- Extensive knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices
- Develop, enhance and maintain strategies and plans to enhance the overall quality of software including test coverage, and system performance
- Work in highly visible, highly demanding environment
- Work unsupervised on multiple tasks, meeting tight deadlines and deliverables
9
Experience For Staff Quality System Engineer Resume
- Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation
- Leads the exercise of understanding the functional inputs and outputs of the medical device
- Plans and verifies that new difficult engineering devices are technically sound and in compliance with FDA and other regulatory bodies
- Plans, performs, and reviews difficult engineering risk analyses to manage technical difficulties encountered with new medical devices
- Leads and/or facilitates periodic design reviews during the product development process
10
Experience For Senior / Staff Design Quality Engineer Resume
- Provides leadership and mentoring to more junior staff
- Proficient in ISO 13485, GDP, GMP
- High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs
- Subject matter expert in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses
- Deputises proficiently for management in temporary absence, periodic review boards, business meetings etc on a regular basis
- Presents as a change agent and adopts a continuous improvement orientation to the role
- Responsible for assuring that each project is developed and released meeting customer expectations, regulatory requirements including 21CFR820, 21CFR11,ISO 13485, ISO 14971, IEC 62304, IVDD 98/79/EEC, and/or MDD 93/42/EEC
- Responsible for development planning, design input, design output, design history file management, design transfer, change management, risk management and design reviews for application and embedded software
List of Typical Skills For a Staff Engineer, Quality Resume
1
Skills For Staff Software Quality Engineer Resume
- Demonstrated root cause and problem solving skills is required
- Excellent communication, interpersonal and leadership skills is required
- Proven experience in leading quality engineering efforts within an engineering team of at least 8-10 engineers
- Work aggressively and effectively with a wide array of personnel ranging from hourly employees to senior management
- Advanced skills on Microsoft Office software, including PowerPoint, is required
- Experience validating systems, equipment and processes in a regulated environment is required
- Communicate effectively with product owners and Development teams. create CI jobs using Jenkins or similar tools and maintain them
- Experience with Java SE/EE, Web Technologies, Web Services/XML/Micro services, Linux/Solaris OS experience
2
Skills For Staff Quality Systems Engineer Resume
- Work closely with Product Management to ensure effective validation of user needs
- Effectively write communications that ensures clarity, accuracy and consideration of the audience
- Effectively train, and influence a diverse array of employees impacted by Quality Systems initiatives and performance measurements is required
- Knowledge of automated testing, and experience with validating automated test scripts is required
- Experience developing test strategies for verification and validation, and managing defects is required
- Transposing knowledge and expertise of manufacturing and inspection methods and their limitations into cost effective design and process solutions
3
Skills For Quality Staff Engineer Resume
- Experience working within a wide variety of automated testing frameworks, including Java, JUnit, Selenium, and Protractor
- Experience in Requirements Management, Reliability Engineering and Quality Engineering is required
- Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR)
- Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES)
- Experience with issue-tracking and agile project management systems such as Jira,, Confluence, Rally, etc
- Provides leadership in the product development process by identifying effective test methods
4
Skills For Customer Quality Staff Engineer Resume
- Work in fast paced environment and rapidly shifting priorities with business and financial acumen is required
- Excellent understanding of requirements management, configuration management, Product Software V&V, defect management and software risk analysis is required
- Experience designing test strategies based on software architecture, requirements and design is required
- Experience working with cloud based systems (Azure, AWS and Google Cloud)
- Experience working with data platforms, large data sets and big data tools
- Expertise or working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff
5
Skills For Staff New Product Quality Engineer Resume
- Lean Six Sigma/4D training and experience required
- Be the voice of Quality when dealing cross functionally. Proven ability to influence multiple stakeholders and ensure the correct outcome
- Experience in (software) quality engineering role in a medical device / IVD company environment
- Experience with post market activities (complaint handling / failure investigations) relative to software
- Hands-on experience with Next Generation Sequencing consumables and chemistry
- Hands-on experience with Software used in Next Generation Sequencing products
- Effective data mining, trend analysis, statistical analysis
6
Skills For Staff Engineer, Advanced Quality Resume
- Hands-on experience with C#/Java development using Object Oriented methodologies
- Works together with SW Quality Engineers to ensure effective verification of design specifications and requirements
- Experience working within a regulated medical device industry
- Experience in product development process and design control
- Knowledge or experience in FDA submissions
- Good knowledge of automated testing processes, methodologies, and software development lifecycles
- Hands-on experience with facilitating software risk assessment sessions is required
7
Skills For Senior Staff Software Quality Assurance Engineer Resume
- Experience in a regulated manufacturing environment is required
- Strong knowledge of Product Software Lifecycle Development process is required
- Challenge designs, verification efforts and approaches through effective and professional communication
- Experience as verification lead for mid / large size NPI
- CRE or equivalent course work / experience desirable
- Experience with a variety of software categories desirable
- Experience in R&D or Quality role
- Professional experience in quality assurance or application development
8
Skills For Staff Design Quality Engineer Resume
- Professional experience in quality assurance or application development
- Experience with relational and flat database architecture and schema designs
- Experience with Linux / UNIX platform based deployments
- Masters of Science, Engineering or related subject with 2 or more years of experience in a quality discipline
- Exhibits strong leadership and mentoring behaviors
- Masters of Science, Engineering or related subject with 2 years of experience
- Exhibits strong leadership and mentoring behaviours
- Excellent team player who feeds off team’s energy and is willing to go the extra mile to meet the team’s objective and goals
- Extensive experience in 8D problem solving activity
9
Skills For Staff Quality System Engineer Resume
- Knowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD)
- Experience applying quality regulation standards (e.g 21CFR820, ISO 13485, ISO 14971, IVDD, ISPE Baseline guides and ASTM E2500-07 Verification Guideline)
- Previous experience in a regulated environment required
- Responsible for leading/guiding computer system validation activities and 21CFR11 applicability and compliance assessments
- Be an effective member of the cross-functional organization to foster continuous quality compliance, cost, and predictive measures improvements
10
Skills For Senior / Staff Design Quality Engineer Resume
- Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance
- Conduct and lead design verification and validation activities
- Drive best practices for design test and inspection method development, and lead method validation activities
- Working closely with suppliers or our manufacturing site in defining, developing and evaluating design and process specifications and their controls
- Leading discussions relating to manufacturing topics and presenting proposed solution
- Leading or assisting in Design FMEA’s and the resolution of any issues identified during development
List of Typical Responsibilities For a Staff Engineer, Quality Resume
1
Responsibilities For Staff Software Quality Engineer Resume
- Excellent interpersonal relations and communication skills are required
- Adjust communication styles for various audiences and work effectively within a multicultural environment
- Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment is required
- Experience auditing to one or more of the following Standards: AS9100, ISO14001, or ISO27001
- A solid understanding of the application of regulations and standards (21CFR 820, IVDD/IVDR, ISO 13485, ISO 14971, IEC62304)
- Collaborates with cross functional team to identify, prioritize and execute business critical quality initiatives
2
Responsibilities For Staff Quality Systems Engineer Resume
- Experience with software maintenance activities (failure investigations/bug fixes)
- Operate flexibly in fast paced environment
- Excellent written and verbal communications required
- Proven ability to work within a team environment and contribute to positive team attitude
- Proven ability to work on problems and projects of complex/ advanced scope
- Experience with enterprise Quality System tools (e.g., electronic CAPA, Complaint Management systems)
3
Responsibilities For Quality Staff Engineer Resume
- Assists in detecting trends/recurring issues; and reports on analysis, makes recommendations, and drives programs to improve products and processes
- Provide training to software development teams, staff, contractors and business partners on ASP software quality engineering procedures
- Continually improve software quality engineering processes. Improve technical expertise and understanding of regulatory requirements
- Masters or Ph.D in Engineering (e.g. systems, biology, biomedical, bioengineering, software), Biostatistics, or Statistics
- Ensures recognition, implementation, training and adoption of unique product standards pertaining TS products
- Provide overall Quality Systems leadership for CRM sites including
- Guide the team on plan and execute white box, grey box testing for SSD Firmware
4
Responsibilities For Customer Quality Staff Engineer Resume
- Expertise or working knowledge of IEC 62304:2006+AMD1:2015
- Expertise or working knowledge of Food and Drug Administration 21 CFR PART 11, Electronic Records; Electronic Signatures
- Expertise or working knowledge of Food and Drug Administration 21 CFR PART 820, Quality System Regulation
- Has indepth knowledge of engineering and quality practices & methods
- BS/BA or equivalent in Computer Science, Engineering, Biological/Life Sciences, or related field required
- Act’s as a domain expert in routine Quality Engineering and scientific matters
- Develop and lead key strategic Quality Engineering/scientific initiatives throughout the organization
- Implement systems to address changing regulations
5
Responsibilities For Staff New Product Quality Engineer Resume
- Represent SWQE function during regulatory inspections
- Leads quality systems design and adaptation for research and engineering activities for overall and specific new products and/or new technologies
- Leads quality systems integration and improvements, including VOC, User Needs, Clinical Measures, Design Inputs, Design Outputs, V&V
- Leads ISO and QSR compliance consulting for NPD, QA and new technologies
- Applies statistical tools to analyze data and identify root cause and problem resolution
- Aggressively identify opportunities to apply, continuously improve, and redefine quality systems and controls for all divisional product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc
- Provide influential leadership with sites to drive proactive quality system improvements
- Represent Quality Systems as required in support of cross-functional divisional projects
6
Responsibilities For Staff Engineer, Advanced Quality Resume
- Support Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Product Development team member focused on product development and life cycle management activities
- Be responsible for establishing and maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA), European Union Medical Device Directives (MOD) and all other applicable global regulatory requirements
- Manage and execute the issues escalations process to ensure critical/ significant quality issues impacting the product in the field are presented to the Quality Review Board for decision in containment/ corrections to be implemented for these in the field
- Implement, revise, execute, and maintain CAPA procedures
7
Responsibilities For Senior Staff Software Quality Assurance Engineer Resume
- Work on complex investigations and coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA actions
- Follow up with action owners on all action items until items are effectively completed and closed
- Track and provide monthly CAPA Performance Metrics
- Act as CAPA Subject Mater Expert (SME)
- Where required, provide back room or front room support for internal, third party, and regulatory inspections and audits as an SME for CAPA, Escalations and Field Actions
- Chair CAPA review board
- Manage, maintain, and improve and standardize Field Action (FA), Issues escalation and CAPA processes to ensure compliance with FDA regulations, ISO Standards and all applicable regulatory authorities requirements
8
Responsibilities For Staff Design Quality Engineer Resume
- Follow all company safety policies and other safety precautions within the work area. Set standards for safe behavior. Recognize and reward safe behavior in others
- Other responsibilities include, but are not limited to: coordinate and participate in special projects as assigned, facilitate technical innovations to enhance Quality Systems and support business goals; act as backup support for CSS product escalation Quality Engineers or other CSS product Field Action and CAPA teams
- Review, approves complex investigations for NC, CAPA and ECI
- Provides quality systems direction, oversight, and guidance to drive global and local initiatives and develop/improve procedures
- Supports internal and third-party [FDA, Notified Body, Customer] quality system audit activities
- Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
- Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CQA, RAC)
- Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records for NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR,
9
Responsibilities For Staff Quality System Engineer Resume
- Develops competency of resources at the site that execute NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, by providing training and guidance on the execution and documentation of these processes,
- Responsible for the timely and compliant execution of site NCs, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR, by championing cross-collaboration across functions, sites, and operating companies; identifying barriers for the progress; and elevating issues for resolution,
- Manages Product Quality Escalations for nonconformances or issues originating at the site, including the initiation, escalation, coordination, tracking, and closure of activities
- Manages on site the timely collection, escalation and reporting of all Quality System metrics to management
- Maintains original documentation for site NC, CAPA, IA Observations, Site Complaint Manufacturing Investigations, Product Quality Escalation, QPR and QSMR as quality records,
10
Responsibilities For Senior / Staff Design Quality Engineer Resume
- Identifies site needs to meet and improve system performance of NC, CAPA, IA Observation, Site Complaint Manufacturing Investigation, Product Quality Escalation, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner,
- Collaborates with Franchise Quality in the deployment (design, implementation, and post-monitoring) of QS initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level,
- Oversees on site Document Control (as required), including management of change documentation, on-site administration of the change control system, and archival of documents on site,
- Support process and product validation programs for new product development
- Represent SW Quality Engineering function during audits
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