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Senior Documentation Engineer - MedTech m/w/d (EN)
[16868]
Documentation Specialist, primary packaging, combination products
Support the strategic growth of the PPMD-PC team by managing documentation and design control activities for primary packaging, medical devices, and combination products used in CSL Behring legacy products. Provide scientific and regulatory support for lifecycle management, post-launch activities, and compliance with global quality and regulatory requirements. Project title: Senior Documentation Engineer - MedTech m/w/d Type of employment: Payroll Industry: Pharma & Medizintechnik Skills: Documentation Specialist,primary packaging,combination products Project start: 01.01.2026 Project duration: 12 Monate Location: Bern, Schweiz Key Responsibilities ·Ensure design control processes comply with ISO 13485, 21 CFR 820, ISO 14971, and EU MDR. ·Maintain and update Design History Files (DHF), verification/validation documentation, and risk management files. ·Incorporate post-market feedback (e.g., product technical complaints) into DHF. ·Prepare and maintain documentation for new and existing primary packaging, medical devices, and related equipment. ·Review and/or approve design control documents including protocols, reports, FMEAs, risk plans, and change management records. ·Support design modifications ensuring adherence to Health Authority requirements. ·Support resolution of findings from internal audits, regulatory inspections, and notified body interactions. ·Prepare corrective actions and responses to inspection issues. ·Execute projects within agreed cost, quality, and timeline expectations. ·Provide clear communication and collaboration across Regulatory, QA, Production, Manufacturing, and Supply Chain. Qualifications ·Minimum 10 years of device development experience in the pharmaceutical industry. ·Strong background in change control, post-market surveillance (ISO 14971, MDR, CAPA), and lifecycle management. ·Strong scientific knowledge of primary packaging and drug-delivery devices. ·Expertise in design control, risk management, and SOP documentation. ·Independent, organized, effective communicator; able to work across all levels. Flexible hours; minimum 60% on-site presence in Bern.
- Ensure design control processes comply with ISO 13485, 21 CFR 820, ISO 14971, and EU MDR.
- Maintain and update Design History Files (DHF), verification/validation documentation, and risk management files.
- Incorporate post-market feedback (e.g., product technical complaints) into DHF.
- Prepare and maintain documentation for new and existing primary packaging, medical devices, and related equipment.
- Review and/or approve design control documents including protocols, reports, FMEAs, risk plans, and change management records.
- Support design modifications ensuring adherence to Health Authority requirements.
- Support resolution of findings from internal audits, regulatory inspections, and notified body interactions.
- Prepare corrective actions and responses to inspection issues.
- Execute projects within agreed cost, quality, and timeline expectations.
- Provide clear communication and collaboration across Regulatory, QA, Production, Manufacturing, and Supply Chain.
- Minimum 10 years of device development experience in the pharmaceutical industry.
- Strong background in change control, post-market surveillance (ISO 14971, MDR, CAPA), and lifecycle management.
- Strong scientific knowledge of primary packaging and drug-delivery devices.
- Expertise in design control, risk management, and SOP documentation.
- Independent, organized, effective communicator; able to work across all levels.
Luca Furler