Quality Engineer

Must Have

• Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
• Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.
• Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Participate when appropriate in audits
• Demonstrates mastery of software development and testing methodologies
• Independently develops test strategies for new, pre-concept features in development.
• Assesses the compliance of the software development methodology to the approved process.
• Facilitates hazard analysis and SFMEA sessions.  Updates the risk management file.
• Acts as the subject matter expert on risk management for one or more products/platforms.
• Ensures applicability to SOUP / OTS validations in the product development
• Participates on CCB to decide upon CR implementation.
• Applies quality system regulations, applicable standards and guidance to multiple projects
• Develops templates and training based on the quality system regulations, applicable standards and guidance.
• Independently reviews all SW deliverables to ensure compliance with development process and the standard.
• Delivers presentations to the QA organization on status and issues of assigned projects.
• Delivers training to departments outside of QA.
• Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.

Minimum Qualification

• B E or B.Tech
• Minimum 3-5 years of quality engineering experience or equivalence and overall 4-7 years of experience

Key Technical Competencies

• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab, Stat Graphics)
• Familiar with ISO 9001, ISO 13485, IEC 62304, ISO 14971, IEC 60601 and product specific industry standards.
• Hands-on experience on Risk Management, Design Controls.
• Computer literate and experience with PCs, networks, and applicationssome travel required
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Good verbal and written communication skills including protocol / report development andtechnical presentations.
• Strong in software design and development, software verification and validation activities
• Knowledge in cybersecurity

Nice to Haves

• ASQ CQE, CQA, CSQE and/or CRE certification.
• ISO 9001 Internal Auditor / Lead Auditor Cerification
• ISO 13485 Internal Auditor / Lead Auditor Cerification

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