Device Quality and Design AssuranceAnalyst Quality Assurance

Description Overview

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.

Scope of the Role

· 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 and regulatory inspections and develop procedures, tools, training, metrics, and governance necessary to strengthen medical device Quality capability.

· Monitor evolving medical device regulations and standards and translate requirements into practical, risk-based expectations for development programs.

Decision-Making and Authority

Exercises independent Quality judgment and may recommend that a project, design review, design transfer, or launch milestone not proceed when required evidence is incomplete or Quality, patient/consumer safety, or compliance risks are not adequately controlled. Escalates significant risks through appropriate Quality and project governance channels. This role has no direct reports.

Experience Required

Education and Experience

· Bachelor's degree in engineering, life sciences, biomedical sciences, Quality, or related technical discipline; advanced degree preferred.

· 7+ years of progressive experience in medical device Quality, design assurance, product development, engineering, regulatory affairs, or a related regulated function, including 4+ years supporting medical device design and development.

· Demonstrated knowledge of design controls, risk management, verification and validation, design transfer, change control, and product commercialization.

· Working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and applicable EU MDR requirements.

· Experience reviewing design and development documentation and participating in formal design reviews or stage-gate decisions.

· Strong ability to interpret technical and regulatory requirements, apply risk-based Quality judgment, and influence multidisciplinary teams without direct authority.

· Strong written and verbal communication skills.

· Ability to travel independently, including overnight travel, based on business needs.

Preferred Qualifications

· Experience with combination products, consumer self-care devices, delivery systems, diagnostics, connected or software-enabled devices.

· Knowledge of applicable standards such as IEC 62366-1, IEC 62304, IEC 60601-1, ISO 10993, packaging/distribution validation, sterilization, and medical device cybersecurity.

· Experience supporting 510(k), De Novo, PMA, IDE, EU technical documentation, notified-body reviews, CE marking, or other global market authorizations.

· Experience with external development partners, contract manufacturers, critical suppliers, supplier Quality, or technology transfer.

· Relevant ASQ, RAC, ISO 13485 Lead Auditor, or comparable certification preferred.