Device Quality and Design AssuranceAnalyst Quality Assurance

Location:

Allegan, MI, US, 49010

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All
. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone
, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

The Pre-Commercial Quality Professional - Medical Devices is an individual contributor responsible for providing Quality leadership and subject matter expertise for medical device and combination-product development from concept through market launch. This role provides independent Quality oversight and partners with cross-functional teams to ensure design controls, risk management, verification and validation, design transfer, and launch-readiness activities meet applicable regulatory requirements, internal procedures, and product quality objectives.

• Provide independent Quality oversight for medical device and device constituent-part development from concept and feasibility through design transfer, regulatory submission support, commercialization, and post-launch handoff.
• Ensure development activities comply with applicable Perrigo procedures, FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and other applicable global requirements.
• Provide Quality oversight of design controls, including user needs, design inputs and outputs, design reviews, verification and validation, design changes, traceability, design transfer, and design and development documentation.
• Oversee product and process risk-management activities and ensure identified risk controls are appropriately implemented, documented, and verified.
• Serve as the Quality representative for project governance, stage-gate, design-review, and launch-readiness activities, assessing Quality deliverables and risks before project progression.
• Review and approve applicable design and development documentation, including requirements, specifications, protocols, reports, risk-management files, verification and validation evidence, usability, software, biocompatibility, packaging, shelf-life, sterilization, and design-transfer documentation.
• Partner with R&D, Engineering, Regulatory Affairs, Clinical, Operations, Supply Chain, Procurement, Commercial, Human Factors, and external partners to incorporate Quality requirements throughout development.
• Provide Quality oversight of external development partners, contract manufacturers, laboratories, and critical suppliers, including qualification, Quality Agreements, audits, technical reviews, issue escalation, and performance monitoring.
• Ensure manufacturing processes, test and inspection methods, tooling, packaging, labeling, sterilization, supplier controls, and other applicable processes are appropriately validated and transferred before commercial launch.
• Lead or support resolution of development-related deviations, nonconformities, design issues, investigations, corrective actions, design changes, and Quality risks.
• Assess launch readiness and ensure effective handoff to Commercial and site Quality organizations, including open risks, monitoring plans, post-market commitments, complaint considerations, and change controls.
• Support audits…