Sr Manager, Quality Engineering & Risk Management

Overseeing the Design Assurance and Risk Management teams
, this role will lead efforts to strengthen the quality, safety, and reliability of diagnostic products on a global scale. This position offers the opportunity to build and expand two critical functions within a highly innovative, mission-driven environment.

You will shape the strategy, vision, and operational framework for integrating Quality and Risk Management throughout the product lifecycle—from early concept through commercialization—ensuring solutions meet regulatory requirements while achieving high standards of performance and patient impact. This role also involves developing and mentoring teams, collaborating with cross-functional leaders, and positioning Quality as a key contributor to successful product development.

Supports design control activities within product development teams, ensuring compliance with applicable standards and regulations and successful design transfer to manufacturing.

Responsible for development and maintenance of product risk documentation including product risk assessments, hazard analysis, fault‑tree analysis, safety risk analysis, and Design Failure Mode and Effects Analysis (DFMEA) across the product lifecycle.

• Ensure compliance with design control processes and applicable regulatory standards
• Manage development and maintenance of product risk documentation including DFMEA, hazard analysis, and fault‑tree analysis
• Monitor and manage post‑market quality data including complaints, deviations, and non‑conformances
• Ensure completion and maintenance of Design History Files (DHF)
• Evaluate quality deliverables during the product development process
• Support regulatory submissions with quality documentation
• Assess quality and validation impact of change orders (ECOs, SCOs, ECRs)
• Support design transfer to manufacturing
• Provide quality oversight during product launch and early commercialization
• Maintain Quality Engineering SOPs
• Provide subject matter expertise during internal, external, and supplier audits
• Participate in design reviews, reliability programs, MRB meetings, and post‑launch surveillance
• Support continuous improvement initiatives using LEAN and Six Sigma methodologies
• Maintain compliance with FDA, ISO, and other regulatory requirements

• BS with 12 years, MS with 10 years, or PhD with 8–10 years of experience in a scientific or engineering discipline
• Experience in relevant IVD and/or medical device industries
• Strong knowledge of QMS systems, FDA regulations, ISO 13485, MDD / IVDD / IVDR / MDR / ISO 14971
• Experience with design control, change control, validation, CAPA management, FMEA, risk management, and root cause analysis
• Experience with electronic document management systems
• Understanding of statistics, SPC, and acceptance sampling
• Knowledge of QSR, CDRH, ISO 13485, ISO 14971, IVDR, IEC 62304, MDSAP, MDR
• Knowledge of 21 CFR Part 11
• Experience supporting FDA and regulatory agency interactions