Quality Manager and Auditor EOQ - Medical Device Quality Management Expert

Establish of a Packaging Line (Form-Fill-Seal / FFS) fpr small implantable medical device Claas Is and II, Planning of Packaging Performance and stability simulations, based on ISO 11607-1/-2, supporting equipment qualification and process validation

Packaging Development of terminally sterile Packaging Systems for medical Devices. Establish and maintain Packaging Development Process for Medical Devices. Plan and coordinate activities for Design Verification of Packaging System Performance and Stability according ISO 11607-1 and ISO 11607-2. Arrange and perform Notifications of Change to Notified Body for terminally sterile products. Design Control/ Change Management for change activities including Risk Management evaluation.

Medical Devices (sterile and non-sterile, Medical Devices Class I, Is, IIa, IIb for breast-feeding equipment) for infant and baby feeding, also as negative pressure therapy

Global Packaging Project for Medical Device Packaging Systems to align Packaging Systems and accomplish full compliance with international standards and regulatory requirements (FDA 21CFR Part 820 and MDD), Design Control/ Change Management for change activities including Risk Management coordination.

Interim Packaging Development Engineer for Packaging Development Remediation and Packaging System Changes, Packaging System Performance Verification and Shelf Life Verification planning according requirements from FDA 21CFR Part 820 and MDD 93/42 EEC; Medical Devices (implants and instruments, sterile and non- sterile, Device Class I-III)

Medical Packages (Pouches and Blister), Medical Devices Class I – III, QM-Process Developmetn (QM/ Documentation, Risk Management Process Validation), Customer consulting for Packaging System Verification and Validation of temporary sterile products acc. ISO 11607 and MDD 93/42 EEC

Development and production of Diagnostic Test- Equipment (Blood- Gas- Sensors, no Medical Device Class).

Measurement Technologies, Process Engineering, Validation Process, Nitinol Semi- Finished Products).

Validation of Processes and Test- Methods, Verifications, Process Engineering in the area of cardio vascular therapies – Catheter- and Nitinol Stent- Production (Medical Devices Class III)

QM- Process- Development (Qualification and Validation, Risk Management, CAPA- Management) and performance of Equipment Qualification and Process Validation in production of Medical Devices (Class I).

Re-New QM- System including Risk- Management, Audit- Process, CAPA- Process (no Medical Device Class only Storage Equipment/ Sample Management Systems)