Design Assurance Engineer Resume Sample
Ethyl Hoppe
4658 Bartell Fork,
Chicago,
IL
+1 (555) 902 2812
Work Experience
Senior Design Assurance Engineer
03/2016
-
PRESENT
San Francisco, CA
- Solid understanding of design control, 21 CFR 820, ISO 13485, EU MDD/MDR, MDSAP, CMDCAS, Brazil RD, Australia TGA, Japan PAL, ISO 14971 and other applicable standards and regulations
- Working closely with product development engineering, clinical, marketing, regulatory, and other business partners to assure appropriate quality requirements are defined for the specific device application and target patient population
- Leading cross functional teams in completing risk assessment and risk management activities
- Supporting PMA submission content and review for compliance to QRS/CGMP regulations
- Being an integral member of product development team responsible for supporting activities required to ensure quality of the design through compliance with design controls
- Working with R&D to create, optimize and validate mechanical and analytical test methods
- Working with cross functional team to plan and conduct design verification activities
Design Assurance Engineer
07/2013
-
09/2015
New York, NY
- Working with cross functional team to plan and conduct human factors and design validation activities
- Working with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to ensure device master record is complete and provide guidance to design engineering, manufacturing and product quality engineering for development of manufacturing test/evaluation methods and process validation
- Working with cross functional team to assess impact of proposed supplier changes
- Working cross-site to support OOS, NCMR and HHA activities
- Supporting compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness
- Providing Support to Post Market Surveillance group
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes
Principal Design Assurance Engineer
12/2009
-
01/2013
Los Angeles, CA
- Mentor other engineers and technicians on the application of quality tools
- Audit, create, and maintain medical device and combination device Design History Files throughout a staged Design Development Process
- Create and execute Design Controls relevant to multiple product categories in a Contract Manufacturing Organization
- Provide project leadership with respect to Design Controls, Risk Management, and Design Verification Test Planning for both Medical Device and Combination Device Products
- Participate on development teams representing Design Assurance Engineering
- Implement, improve and maintain Quality Management System procedures compliant with ISO 13485:2016, ISO 14971:2012, and 21 CFR 820 (specifically 820.30)
- Supporting Internal, External, and Customer audits as they relate to Design Controls
Education
University of Maine at Farmington
2004 - 2009
Engineer's Degree in Engineering
Professional Skills
- Excellent verbal communication skills and technical writing capability
- Excellent analytical problem solving and organizational skills
- Strong communication (verbal and written), teamwork and organizational skills
- Excellent verbal and written communication skills using the English language
- Skills in personal computer spreadsheet, word processor and engineering tools
- Teach and develop management, organizational, and engineering skills of junior departmental personnel
- BS in Engineering field with 9-13 years of relevant experience OR MS with 7-11 years of relevant experience
How to write Design Assurance Engineer Resume
Design Assurance Engineer role is responsible for interpersonal, security, training, integration, procurement, auditing, architecture, reporting, manufacturing, design.
To write great resume for design assurance engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Design Assurance Engineer Resume
The section contact information is important in your design assurance 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 Design Assurance Engineer Resume
The section work experience is an essential part of your design assurance 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 design assurance 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 design assurance engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Design Assurance Engineer resume experience can include:
- Team player with good interpersonal skills and ability to communicate confidently and persuasively with a wide variety of people
- Technical skills in product validation
- Demonstrated experience managing multiple projects covering diverse engineering disciplines (examples: Systems, Hardware, Software, Firmware)
- Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards
- Demonstrated experience carrying out engineering calculations and analysis
- Proven experience in leading complex system analysis from early stages to post release
Education on a Design Assurance Engineer Resume
Make sure to make education a priority on your design assurance engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your design assurance 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 Design Assurance Engineer Resume
When listing skills on your design assurance 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 design assurance engineer skills:
- Strongly demonstrated verbal and written communication skills
- Team oriented with strong mentoring skills
- Excellent communication skills and the ability to learn quickly
- Strong oral and written communication skills. Ability to communicate technical information to non-technical audiences
- Detail oriented with good organizational and record keeping skills
- Excellent oral and written communication, and interpersonal skills
List of Typical Experience For a Design Assurance Engineer Resume
1
Experience For Senior Design Assurance Engineer Resume
- Knowledge/Experience with Cloud Computing and Cloud Networking
- Experience in Quality Engineering in a medical device industry
- Manage statistical support for test method validations, sample size requirements, etc
- DOE and GR&R experience
- Experienced in Statistical analytics, Advanced SPC, Quality Analysis Tools and DOE
- Assists in the determination of sample size, confidence levels, and associated statistics pertaining to verification and validation activities
- Analysing, reducing and managing risks associated with the design, use and manufacture of BSC devices
- Supervising, leading and coaching members of the design assurance department
- Understanding of engineering concepts and principles
2
Experience For Principal Design Assurance Engineer Resume
- Leading cross functional teams in completing human factors activities
- Working with cross functional teams to plan lot release requirements for releasing clinical product
- Understanding and complying to BSC’s quality, business, health & safety systems and market/legal regulations governing the quality systems
- Removing or mitigating against risks associated with the design, use and manufacture of BSC devices
- Working with SW development group to continuously improve software development processes and compliance with 62304 and internal BSC SOPs
- Promoting and effecting compliance to BSC’s quality, business and health & safety systems and market/legal regulations
- Executes tactical implementation of strategic plans regarding quality engineering input to projects
- Support the pilot manufacturing line by performing Design Assurance Review and NCMR support
- Assists in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions
3
Experience For Associate Design Assurance Engineer Resume
- Track record of ushering in or working with Unit Test Frameworks
- Document test results, tracking any outstanding issues to closure
- BS in Engineering, Bioengineering
- Basic knowledge/understanding of valve testing/kinematics
- Responsible for design history file auditing
- Manage product stability program to ensure all products have adequate heat-age and real-time aging for support of shelf life
- Able to develop test protocols and synthesize data to write test reports based on observed data, relevant test standards and general engineering knowledge
- Leads risk management activities throughout the product life cycle, including Preliminary Hazard Analyses, DFMECAs, PFMECAs, and UFMECAs
- Assists in the preparation and design of presentation materials summarizing results of reliability assessments
4
Experience For Senior Software Design Assurance Engineer Resume
- Contributes to and executes quality engineering schedules and plans
- Reviews and approves written protocols and reports and engineering documentation as necessary
- Assures compliance with company Standard Operating Procedures and policies
- Prepares verbal updates and presentations for various activities and trending, as needed, at company meetings
- Works with all departmental personnel in the execution of engineering projects
- Works with engineering team members on team assignments and projects as necessary
- Interacts with management on trouble shooting of production problems and changes as necessary
- Interacts with management in the preparation of engineering change documents
- Lead CtQ efforts during new product introduction process to assure robust and efficient launches of new and innovative healthcare products
5
Experience For Design Assurance Engineer, Principal Resume
- Support review of Agile Change Requests and Change Orders for new and sustaining products
- Assess change requests of product for impact to design, determine supporting information required for implementation of changes
- Coordinate new process techniques that improve overall job efficiencies
- Coordinate product and process risk management assessments
- Coordinate the implementation of design transfer
- Create and maintain device master records
- Manage the stability test program
- Perform standards review for all relevant processes (ISO 13485, 14971, etc)
- Provide cross-functional support with Coloplast personnel and external physicians
6
Experience For Design Assurance Engineer Resume
- Interacts with external contract manufacturers and suppliers
- Provide technical support based on overall project plans with the development of products in compliance with design controls, international standards, and FDA or other regulatory body guidances
- Complete relevant tasks to fulfill major milestones, identifying key parameters and all other requirements for products
- Obtain and maintain all necessary information and experimental test results related to assigned projects by various means of recording
- Perform requirements tracing for product development to ensure complete coverage
- Familiarity with statistical analysis (e.g. two-sample t-test, tolerance limit calculation)
7
Experience For Senior Design Assurance Engineer Resume
- Familiarity with FDA, ISO and EN Standards as they apply to medical devices
- Familiarity with failure mode analysis (FMEA, Fault Tree Analysis) and other risk management procedures
- Leads/participates development of Risk Management documentation
- Lead/assist in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions
- Participate/assist in audits and inspections of the company and our quality systems
- Provide design assurance activities, reviewing contractors’ designs and NEC-3 Project Manager’s acceptance of contractors’ designs for the Main Work Contracts
- Understanding of hydraulics and experience in design of hydraulic structures and control mechanisms associated with sewerage infrastructure projects within the UK, particularly, the design of CSO’s and/or deep storm sewers/wastewater pumping stations
- Able to drive activities to closure
- Working with Software development cross-functional team to identify and implement effective controls to support the development, qualification, commercialization, and sustaining activities of products to meet or exceed internal and external requirements
8
Experience For Principal Design Assurance Engineer Resume
- Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Product Specification, Design Review, Design V&V, SW Validation, Test Methods, Process Validation, Labeling)
- Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in BSC
- Assists with the analysis and resolution of design or manufacturing problems as these arise during the development process
- Generation of Quality deliverables such as Quality and Field Assessment Plans
- Providing quality and compliance input and coaching for post market product sustaining activities, such as design changes, supplier auditing and surveillance, product marking and safety certification, customer complaints, PIRs and CAPAs
- Reviewing and providing feedback to R&D and Software Quality team on their deliverables including Software Development Plan, Risk Management, V&V Plan, test cases, trace matrix, etc
- Work closely with R&D and Software Quality teams
9
Experience For Associate Design Assurance Engineer Resume
- Support and review the creation and maintenance of DHF’s, Technical Files and similar documents
- Ensuring their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work
- Guides new product development and design changes ensuring product quality, reliability, speed to market, reduction of risk to users and patients, and regulatory compliance
- Reviews and approves verification and validation methods for sterile medical devices, including performance, biocompatibility, sterilization, and manufacturing processes to ensure design input is met
- Responsible for Risk Management, documentation, and assurance that Design and Manufacturing process changes are assessed for potential risks to patients or regulatory compliance
10
Experience For Senior Software Design Assurance Engineer Resume
- Assists the Quality Assurance function to build a comprehensive Design Assurance system compliant to FDA requirements, by reviewing Design Control procedures and policies, and assisting in document writing
- Provides assistance and mentorship to company manufacturing locations to implement an improved and robust Design Control system
- Reviews product change notices and change documentation to ensure thorough review of quality documents submitted for technical changes, design changes or manufacturing changes in order to ensure all regulatory requirements related to these changes are completely followed and conform to the Design Control regulations
- Lead complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solve a wide range of difficult problems in creative and effective ways
- Develops or participates in establishing requirements for all verification and validation (design and process) activities
- Executes quality engineering deliverables required by the Product Development Process
- Mentors junior Design Assurance Engineers as required
- Analyzes and investigates returned clinical investigation products to determine the cause for return
- Contributes to design input requirements from experience with previously reported problems, Medtronic products, competitive devices and/or other similar products
List of Typical Skills For a Design Assurance Engineer Resume
1
Skills For Senior Design Assurance Engineer Resume
- Participates in developing master test plans that encompass design verification, design validation and process validation activities
- Effectively present information and respond to questions from managers, sales personnel, and customers
- Experienced in effective and compliance design transfer of new products and technologies in production environment
- Technical skills and ability to provide solutions to a variety of technical problems of moderate scope and complexity
- Prior medical device industry experience
- Experience with development of Design Input and traceability through verification and validation V&V activities
- Proven experience with lean manufacturing and six sigma processes
2
Skills For Principal Design Assurance Engineer Resume
- Experience in validation testing of product designs
- Working knowledge & experience testing complex hardware/software systems in a structured environment
- Working knowledge & experience in testing User Interface software in a Microsoft Windows environment is desirable
- Working knowledge & experience in configuration management
- Working with cross functional teams to plan and conduct process validation activities
- Working knowledge of verification and validation requirements for a regulated product
- Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both Cerenovus and their customers
- Experienced in planning, executing and reporting Design Verification
- Experience investigating complaint or design issues, conducting risk/root cause analysis and insuring compliance to quality standards
3
Skills For Associate Design Assurance Engineer Resume
- Lead in the testing, verifying and validating new and updated designs to meet or exceed internal and external requirements
- Previous experience with leadership, mentoring, project management and problem solving
- BS in Engineering, Bioengineering with 2 years’ experience
- Experience with reviewing and maintaining design history files
- Experience performing statistical analysis including Measurement System Analysis,
- Knowledge and understanding of Good Manufacturing Practices and other applicable standards
- Lead in the testing and validation of new and existing designs to meet or exceed internal and external requirements
- Experience in Quality Assurance, including Quality systems, standards, metrics, and tools desirable
4
Skills For Senior Software Design Assurance Engineer Resume
- Demonstrated ability to provide statistical guidance in the sampling activities executed for Design Verification
- Proven track record of leading teams from various functions and sites
- Solid understanding of design controls and risk management (ISO 13485, 21 CFR 820 and ISO 14971)
- Pre or post market quality engineering experience in medical devices/technology company
- Experienced in risk management analysis techniques including Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA)
- Knowledge of design verification and design validation for new products and modifications to existing products
5
Skills For Design Assurance Engineer, Principal Resume
- Strong working knowledge of design controls as required by FDA 21 CFR 820.30 and ISO 13485
- Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971)
- Experience working with medical devices or in a highly regulated environment
- Pre or post market quality engineering experience in medical devices/technology company
- BS in Engineering with 2+ years of experience within Quality or related discipline
- Experience writing verification protocols
- Experience with risk management process, including topical risk assessments and write ups
- Works with RA/QA management and other RA/QA personnel to assure that products are developed and validated according to quality system requirements
- Experience in Quality or Design Engineering position
6
Skills For Design Assurance Engineer Resume
- Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing
- Support the testing and validation of new designs to meet or exceed internal and external requirements
- Quality or engineering experience
- Provide critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements
- Experience in Medical Devices preferably HLD/Sterilants, Pharmaceuticals/OTC, Detergents, or liquid/lotion/cream
- Validate that products for test and/or release are from the correct controlled baseline
- Strong knowledge of risk management and design controls required
7
Skills For Senior Design Assurance Engineer Resume
- Medical device and/or clinical experience
- Experienced in Evaluation and Characterization
- Experience with medical devices, in particular cardiac implantable devices
- GMP, QSR, ISO 13485, and ISO 14971 experience
- Work experience in a related quality role
- Experience and / or proficient with
- Process Development, Characterization, and Validation
- Experience with combination drug/medical device products
8
Skills For Principal Design Assurance Engineer Resume
- Experience in product & process development
- Experience of tunnel design and construction and its likely effects on third-party assets
- Experience and knowledge of 62304, 60601 and other industry standards for EME
- Providing critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements
- Experience designing and building high-accuracy, high-reliability medical device systems
9
Skills For Associate Design Assurance Engineer Resume
- Proven track record of driving cultural change advocating SW Quality
- Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements
- Work experience with BS in Engineering or related technical discipline
- Material knowledge of nitinol and any experience with testing of nitinol is desirable
- Experience in Quality Engineering in medical device industry
- Experience in related areas, e.g. R&D or Manufacturing
10
Skills For Senior Software Design Assurance Engineer Resume
- Experience in Quality Assurance, including Quality systems, standards, metrics, and tools desirable
- Experience as a core team member to take design from concept into production
- Design assurance compliance experience in risk management and design controls
- Quality assessment experience in compliance to regulatory guidance and standards
- Works with cross functional team to plan and conduct process validation activities
- Experience in product & process development
- Experience in the Medical Device or highly regulated industry
List of Typical Responsibilities For a Design Assurance Engineer Resume
1
Responsibilities For Senior Design Assurance Engineer Resume
- Standards review, documentation of evidence of conformity
- Review and approve Design Verification and Design Validation test protocols and reports
- Assures regulatory compliance in the area of verification and validation of the Essential Requirements product development process
- Supports sustaining engineering efforts on commercialized products
- Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds
2
Responsibilities For Principal Design Assurance Engineer Resume
- Assesses potential material and component suppliers
- Assists in component qualification activities
- In collaboration with product development, formalize new clinically relevant testing methodologies and approaches required to complete comprehensive reliability analyses of device designs. Participate in verification and validation activities and analyses required to satisfy both regulatory and internal Medtronic requirements
- Participates in design trade-off studies and design sensitivity analyses to identify reliability-critical design variables
- Serves as a technical resource for problem investigations to guide root cause analysis and corrective action development
3
Responsibilities For Associate Design Assurance Engineer Resume
- Provide Design Assurance support and oversight for product development activities throughout product lifecycle
- Ensures product development follows company procedures and design control requirements
- Ensure compilation and maintenance of product Design History Files. Perform DHF audits as an independent reviewer
- Drive robust design reviews within R&D teams
- Oversee and ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards. Promote a “do no harm culture”
- Leads the risk management process for pre-market and post-market assessments of assigned products. Maintains the Risk Management File during the product’s lifecycle
4
Responsibilities For Senior Software Design Assurance Engineer Resume
- Guide the use of robust statistical techniques throughout new product development and design changes
- Supports external regulator or customer audits
- Support the TPI Assessments Manager in carrying out the design assurance of the TPI assessments undertaken by contractors for buildings, utilities and other structures, including i) the design of any mitigation works, ii) required monitoring and surveys and iii) close out reporting
- Attend technical meetings with the contractors and third parties if required, with the TPI Assessment Manager, Delivery Area Leads and TPI Stakeholder Leads
- Deliver signed-off Technical Approval assurance documents in a timely fashion to meet the requirements of the construction programme
- Manage the Thames Tideway Tunnel Asset Register Database, insofar as it relates to third-party utilities, buildings and other structures
- Manage the data already gathered by the project on these assets and manage the procurement of any additional information required by the Thames Tideway Tunnel team. Become familiar with all third-party utilities, buildings and other structures and information gathered, including any additional information obtained from the contractors
- Review the production of AIP Submissions and any required qualifications, e.g. asset inspections, assessments and monitoring, produced by the contractors and the subsequent signoff by the various asset owners and/ or other consenting bodies
- Engage as required with the contractor’s TPI assessment teams to ensure deliverables meet quality requirements, cost and programme
5
Responsibilities For Design Assurance Engineer, Principal Resume
- Review the outcomes of any asset assessments for utilities, buildings and other structures i.e. mitigation works, ensuring that these works are planned, defined and scheduled in the overall programme of works and review the design of the mitigation works by contractors
- Manage the project risk register insofar as it relates to works associated with third-party asset protection for utilities, buildings and other structures
- Identify areas for improvement and communicate them to management to ensure continual improvement
- Ensure that other project functions e.g. West, Central and East Delivery Teams, TPI Stakeholder Leads, Environment and Planning are aware of constraints and issues created by third-party assets for utilities, buildings and other structures and manage dissemination of appropriate information to other disciplines
- EU resident or eligibility to work in the EU
- Chartered Engineer - desirable
- Colaborates in the development in design controls for human tissue based products
6
Responsibilities For Design Assurance Engineer Resume
- Works with PD and Clinical to support IND filings
- Participates in team decision-making and independently performs Quality Engineer’s role in a project, including all elements of Risk Management (RMP, HA, FMEAs)
- Employs team problem solving and communication skills to resolve problems
- Stays informed and serves as subject matter expert about applicable new rules, regulations, and standards that apply to medical devices for product development or change
- Reviews and approves engineering test protocols for testing of component parts and integrated assemblies as is consistent to development/verification/validation activities
- Medical Device/Drug Development experience
7
Responsibilities For Senior Design Assurance Engineer Resume
- Reviews and approves engineering activities directly related to product development at the supplier’s site
- Works with RA/QA management to support all areas of the business, as required
- Works with all functional departments to ensure proper management of interdepartmental projects
- Works within a team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements
- Works within a team to identify and implement effective controls to provide ongoing support for commercialized products to meet or exceed internal and external requirements
- Assure Smiths Medical new product introductions and product sustaining activities are in compliance with applicable FDA/EU regulatory requirements and Smiths Medical Policies and Procedures
- Support deployment of internal development procedures including Design Control, Risk Management, Design Verification, Design Validation, and Statistical Techniques to the product development teams
8
Responsibilities For Principal Design Assurance Engineer Resume
- Assure conformance to industry related regulations within the framework of Smiths Medical product and sustaining development processes
- Interact and form constructive working relationships with all levels of leadership within Global Quality and Regulatory (GQR), Global Product Management (GPM), R&D, Advanced Manufacturing Engineering (AME), Sourcing, Operations, and Service/Repair
- Works within a cross-functional team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements
- Participate in risk management activities including the creation of the preliminary hazard analysis, Design and Use FMECAs, Post Market Surveillance (PMS) Reports and support risk management document changes due to post market quality activities (PEC, IIA etc)
- Represent the Quality function on product and process development project teams. Actively support and engage in Design Reviews, Technical Reviews, Clinical Readiness Reviews, and Manufacturing Transfer Reviews
- Providing expertise in BSC’s product development systems to project teams
- Be a member of the engineering change control board performing the quality approval for change requests
- Supports planning design assurance activities
9
Responsibilities For Associate Design Assurance Engineer Resume
- Evaluate test protocols and reports to confirm the testing objectives have been met
- Perform design/product risk assessment using limited set of data as well as reliability and life data analysis
- Lead the maintenance and deployment of company procedures, codes of practice, forms and other guidance material as relevant to the Engineering department
- Serve as a Site Representative of the TMVR Venture. Maintain site QA Agreements, support biannual TMVR QMR, and support all TMVR internal and external audits
- Ensure Twelve QMS compliance and support activities to prepare the QMS to support commercialization
10
Responsibilities For Senior Software Design Assurance Engineer Resume
- Ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review
- Develop master test plans that encompass design verification, design validation and process validation activities
- Ensuring commitment to training requirements and understanding and complying with all regulations governing their work
- Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality in BSC
- Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry
- Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices. Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements
- Interprets and defines design assurance requirements and processes in compliance with site QPM and product installation/certification environment
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