Design Quality Assurance Engineer

The Design Quality Assurance Engineer is responsible for ensuring Design Control compliance throughout the full product development lifecycle for contract development and contract manufacturing programs serving aerospace, defense, and medical device customers. Working closely with a team of Design Engineers and Program Managers, this role serves as the embedded quality authority for all design and development activities — from design planning and inputs through design transfer — ensuring that all regulatory, customer, and internal quality requirements are consistently met. This position is responsible for training the Design Engineering team in Design Control requirements, actively monitoring adherence throughout development, and ensuring that products are completely transferred into Manufacturing in a state of full regulatory and quality compliance.

Principal Responsibilities

Design Control Compliance & DHF Management

• Serve as the embedded quality authority on Product Development Project teams, ensuring all product development activities are performed and documented in compliance with applicable Design Control requirements (FDA 21 CFR Part 820, ISO 13485, etc.) from design planning and inputs through design transfer and design changes.
• Review and provide approval or concurrence on Design Control deliverables, including design inputs, outputs, reviews, V&V protocols and reports, design transfer, and change orders; maintain and audit the Design History File (DHF) for completeness, traceability, and compliance at all stages of development.
• Identify and escalate Design Control gaps, deviations, or risks to project and quality leadership in a timely manner, and drive resolution.

Training & Design Engineering Support

• Develop, deliver, and maintain a Design Controls training program for the Design Engineering team; provide day-to-day coaching on Design Control requirements and documentation expectations throughout the development process.
• Participate in design reviews as the quality representative, ensuring review criteria are met, action items are tracked to closure, and outcomes are documented in the DHF.

Risk Management, Verification & Validation, and Design Transfer

• Support and facilitate risk management activities (FMEAs, hazard analyses) in accordance with ISO 14971, AS9100, and applicable customer requirements throughout the product lifecycle; ensure risk management is integrated into the development process and residual risks are accepted prior to design transfer.
• Review and approve V&V protocols and reports, ensuring design outputs are fully traceable to design inputs and acceptance criteria are objective and pre-defined; ensure test failures are appropriately investigated and documented.
• Lead the quality aspects of design transfer, ensuring the DMR or equivalent technical documentation package is complete, accurate, and approved prior to manufacturing; collaborate with Manufacturing Engineering and Operations to confirm that production processes, equipment qualifications, and inspection methods are established and capable; confirm transfer readiness criteria are met and documented before production release.

Audits & Nonconformances

• Support internal and customer audits related to design and development activities, including preparation of design control records and participation in audit responses and corrective actions; investigate design-related nonconformances, perform root cause analysis, and ensure effective CAPAs are implemented and closed in a timely manner.

Training, Skills, Knowledge and/or Experience

• 5+ years of quality engineering experience with direct involvement in product design and development activities in the medical device required; Prior equivalent defense/aerospace industry experience a plus.
• Fluent in QMS requirements as established in FDA 21 CFR Part 820, ISO 13485, ISO 14971, and AS9100 design and development requirements.
• Demonstrated experience maintaining DHFs, reviewing and approving V&V protocols and reports, and supporting design transfer activities; experience in a contract development and/or contract manufacturing environment is a plus.
• Fluent in Microsoft Office 365 Suite. Familiarity with electronic QMS, PLM, or ERP systems preferred.

Competencies

• Thorough working knowledge of Design Control regulations and standards, with the ability to translate regulatory requirements into practical, actionable guidance for engineering teams.
• Proven ability to train, coach, and guide engineers and cross-functional team members on quality and compliance requirements in a collaborative, constructive manner.
• Strong attention to detail; able to assess documentation completeness and compliance, identify gaps, and drive timely resolution without unnecessarily compromising program schedules.
• Excellent verbal and written communication skills; ability to manage multiple concurrent programs, prioritize effectively, and operate independently in a fast-paced environment. Strong organizational and interpersonal skills.

Supervisory Responsibility

None.

Educational Requirements

• Bachelor’s degree in engineering or other technical field, or an equivalent combination of education and work experience.
• Relevant certifications (e.g., ASQ CQE, RAC, or equivalent) preferred.

Working Conditions

• Office and controlled manufacturing environments, including engineering laboratory environments and ISO class 7 cleanrooms. PPE required when in controlled environment rooms and cleanrooms.
• May require occasional travel (<10%) in support of customer audits or program reviews.