Device Quality Manager – Global Design Assurance
About The Position
As a Device Quality Manager – Global Design Assurance, you will be a key part of the Global Device Quality organization, which has end-to-end responsibility for the quality aspects of medical devices, drug-device combination products, and packaging. You will act as quality partner, ensuring the drug/device combination product pipeline is delivered with the highest standards of safety and compliance. Drive Quality by Design: Act as the Subject Matter Expert (SME) on the quality aspects of design controls and risk management, to ensure quality and reliability are integrated from the start. Lead Complex Quality Projects: Serve as the Quality Single Point of Contact (QSPOC) for device and packaging projects, managing the journey from development through industrialization and product lifecycle. Collaborate across the Network: Work at the interface between Global Device Quality and stakeholders including QA/QC teams, device development, device industrialization, technical regulatory. Master Compliance: Lead the Device community through internal and external inspections, ensuring audit preparedness across cross-functional teams. Solve High-Impact Problems: Quality assurance of change control, CAPAs, and Deviations, using systematic root cause assessments (RCA) to drive continuous improvement. Innovate Processes: Influence the future of quality by integrating AI tools and Lean/Agile methodologies into everyday quality workflows.
Requirements
- Degree in an engineering or life science discipline and relevant experience: Bachelor's and 7+ years, OR Masters and 5+ years, OR PhD and 3+ years.
- Working knowledge of ISO 13485, 21 CFR 820, EU MDR and ISO 14971.
- Sound understanding of Quality Compliance, Quality Engineering, and Audits & Inspections Management in drug/device combination products and medical devices.
- Ability to educate teams and organization on Design Controls as it applies to medical devices and drug/device combination, and related topics.
- Demonstrated capability of applying risk management concepts and tools.
- Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing.
- Fluency in English
- Demonstrated problem-solving and decision-making skills including hands-on working experience with quality-related tools, Six Sigma and root cause assessment (RCA).
Responsibilities
- Act as the Subject Matter Expert (SME) on the quality aspects of design controls and risk management.
- Serve as the Quality Single Point of Contact (QSPOC) for device and packaging projects.
- Work at the interface between Global Device Quality and stakeholders including QA/QC teams, device development, device industrialization, technical regulatory.
- Lead the Device community through internal and external inspections, ensuring audit preparedness across cross-functional teams.
- Quality assurance of change control, CAPAs, and Deviations, using systematic root cause assessments (RCA) to drive continuous improvement.
- Integrate AI tools and Lean/Agile methodologies into everyday quality workflows.
Benefits
- Discretionary annual bonus may be available based on individual and Company performance.
- Qualifies for the benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
