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Device Quality and Design Assurance Analyst
Perrigo Company plc. 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 .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Quality oversight for medical device development, ensuring compliance with FDA regulations and ISO standards while effectively managing risk and documentation throughout the product lifecycle.
Highest-signal resume keywords
Quality OversightDesign ControlsRisk ManagementRegulatory ComplianceDocumentation Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Design AssuranceVerification And ValidationChange ControlProduct CommercializationRisk-Based Quality JudgmentTechnical Documentation ReviewRegulatory Submission SupportMedical Device Design And DevelopmentQuality Management SystemsCombination Products
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationInfluencing Multidisciplinary Teams
Tools & Technologies
FDA 21 CFR Part 820ISO 13485ISO 14971EU MDRIEC 62366-1IEC 62304IEC 60601-1ISO 10993
Certifications & Qualifications
ASQ CertificationRAC CertificationISO 13485 Lead Auditor
Industry Keywords
Medical DeviceDesign TransferRegulatory AffairsSupplier QualityClinical Operations
Tech Stack
Tools & technologiesCyber Security
About the role
Key responsibilities & impact- 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 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 risk controls are implemented, documented, and verified
- Serve as the Quality representative for project governance, stage-gate, design-review, and launch-readiness activities
- Review and approve 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
- Provide Quality oversight of external development partners, contract manufacturers, laboratories, and critical suppliers
- Ensure manufacturing processes, test and inspection methods, tooling, packaging, labeling, sterilization, supplier controls, and other processes are validated and transferred before commercial launch
- Lead or support resolution of 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
- Support audits and regulatory inspections and develop procedures, tools, training, metrics, and governance
- Monitor evolving medical device regulations and standards and translate requirements into practical, risk-based expectations
- Exercise independent Quality judgment, escalate significant risks, and recommend delaying milestones when evidence or controls are inadequate
Requirements
What you’ll need- Bachelor's degree in engineering, life sciences, biomedical sciences, Quality, or related technical discipline
- 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
- Experience with combination products, consumer self-care devices, delivery systems, diagnostics, connected or software-enabled devices preferred
- Knowledge of IEC 62366-1, IEC 62304, IEC 60601-1, ISO 10993, packaging/distribution validation, sterilization, and medical device cybersecurity preferred
- Experience supporting 510(k), De Novo, PMA, IDE, EU technical documentation, notified-body reviews, CE marking, or other global market authorizations preferred
- Experience with external development partners, contract manufacturers, critical suppliers, supplier Quality, or technology transfer preferred
- Relevant ASQ, RAC, ISO 13485 Lead Auditor, or comparable certification preferred
- All application materials, including resumes and CVs, must be submitted in English
Benefits
Comp & perks- Competitive compensation
- Benefits tailored to supporting you and your family
- Career development opportunities
- Total Rewards benefits package