Sr QA Engineer - Design Control

We are seeking a Sr. Quality Engineer - Design Control to lead the design control activities across the IVD product lifecycle, ensuring compliance with ISO 13485, IVDR, FDA QSR, ISO 14971 and other global regulatory requirements. This role will serve as the primary Quality partner to R&D and cross-functional teams, driving robust design control execution, effective risk management, end-to-end traceability, and sustained audit readiness. The ideal candidate will bring hands-on experience leading design control and risk management activities in a regulated IVD environment, including products developed under ISO 13485 and IVDR.

Responsibilities:
• Serve as the QA lead on cross-functional product development teams, ensuring design control requirements (FDA 21 CFR 820.30, ISO 13485, IVDR) are incorporated from planning through commercialization.
• Ensure compliance with all applicable standards, regulations, and internal SOPs throughout the design and development (D&D) process and design changes. Provide guidance on Quality System requirements related to design and development (design history file, design inputs, design outputs, V&V plans and reports, design transfer, device master record etc.) and design changes.
• Lead risk management activities for projects under design control, ensuring risk management activities comply with internal procedures, ISO 14971, and applicable regulations. This involves issuing the Risk Management Plan and Risk Management Report, leading cross-functional risk management activities including hazard analysis, risk assessments, and ensuring effective risk control measures, residual risk acceptance, and link risk to design changes and CAPAs.
• Support design verification and validation activities by reviewing protocols and reports to confirm that design outputs meet design input requirements and that analytical and clinical performance is demonstrated. Help resolve any discrepancies through root cause analysis and corrective actions.
• Ensure ongoing design control compliance for design and post market changes, maintaining DHF integrity throughout product lifecycle.
• Participate in internal and external audits, serving as the SME for design control and risk management, preparing audit responses, and leading remediation activities.
• Proactively identify any gaps in compliance and lead CAPA initiatives related to design control or development process issues.
• Evaluate and implement process improvements to enhance efficiency, compliance, and scalability as the portfolio grows.
• Develop metrics and KPIs related to design control effectiveness and compliance.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

• Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field.
• 7+ years of experience in Quality Assurance or Quality Engineering in the medical device or IVD industry, with a strong focus on design controls and new product development. Prior experience driving QA in cross-functional product development teams is essential.
• In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management.
• Hands-on experience with risk management per ISO 14971, design history files, verification & validation, CAPA, and change control.
• Demonstrated ability to review DHF documentation (design inputs, design outputs, Verification/Validation protocols and reports etc.) for compliance. Comfortable interpreting engineering documentation, specifications, and test data for compliance.
• Experience managing complex DHF structures digitally.
• Experience with IVD assay lifecycle (development through commercialization).
• Experience with SaMD or algorithm lifecycle management.
• Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses.
• Strong problem-solving and organizational skills to manage multiple priorities.
• Ability to work independently and proactively in a fast-paced environment.
• Attention to detail in understanding and documenting complex quality issues

• Relevant certification (e.g., ASQ Certified Quality Engineer, Six Sigma, ISO 13485 Lead Auditor)

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.