Packaging/Medical Device Quality Specialist
On-site · Bern, Bern, Switzerland
Job Summary
Packaging/Medical Device Quality Specialist for CP/MD QA leading design controls and regulatory compliance across global teams. Responsible for ensuring design and development activities meet FDA, EU MDR, and global requirements, maintaining a 21 CFR Part 4/ MDR compliant quality system, and providing QA expertise in medical device and combination product development. Works with internal/external partners to ensure risk analysis, statistical data analysis, sampling plans, and vendor audits meet CSL standards. Supports development and implementation of quality systems, maintains documentation databases (standards lists, vendor certificates, test method validation logs), conducts root cause analysis, and recommends process improvements. Requires a Bachelor’s degree in a relevant field and 3+ years in medical devices/combination products quality, with knowledge of applicable standards and regulatory guidance; preferred experience with drug-delivery combination products and embedded software/mobile/connected health products.
Required Qualifications
- Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a relevant discipline
- Minimum 3 years of experience as a quality, packaging, engineering, or manufacturing professional in the medical devices or combination products field
- Competencies in medical device and combination product regulations (21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, FDA guidance) and their application in QMS
- Minimum 2 years of practical experience in medical devices R&D Quality, including design controls, NPD lifecycle, requirements specs, risk management (FMEA), V&V, usability/human factors, DHFs, design transfer
- Excellent communication and collaboration skills; problem-solving; planning and organization
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