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Production Specialist

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Production Specialist

PURPOSE OF THE ROLE

Manufacturing of high-quality medical devices according to ISO 13485 requirements. Actively participate in continuous quality improvement to increase product performance, manufacturing efficiency.


RESPONSIBILITIES AND TASKS


Manufacturing and packaging of medical devices:

- Inspection, measurements and cleaning of parts;

- Mechanical assembly and testing of parts and sub-assemblies;

- Managing the  of parts, sub-assemblies and medical devices;

- Maintaining accurate storage conditions and inventory status records for all parts, sub-

assemblies and devices;

- Packaging and labeling of devices;

- Preparation of test samples for quality control testing;

- Documentation of manufacturing activities and preparation of batch records;

- Maintenance of the ISO 6 clean room including cleaning, environmental control and monitoring;

- Participate in production planning and in the continuous management of suppliers (ordering, quality, lead-time, validation etc);

- Support other activities in the department.

Process Development and Validation:

- Participate in continuous quality improvement projects and development of new devices and accessories;

- Participate in the development of new measurement setups and jigs for manufacturing of

devices;

- Participate in the writing of manufacturing and quality control procedures;

- Participate in the writing of technical documentation and reports (in close collaboration with QA/RA);

- Perform scheduled validation of manufacturing processes and routine calibration of equipment;

- Contribute to process development and change control activities for the manufacturing of

medical devices and accessories.


PROFILE:

- At least three years' experience in the manufacturing of medical devices in clean room

environment;

- Excellent organizational skills and punctuality to meet schedules and deadlines;

- Experience in working according to CE Mark and ISO 13485 requirements;

- Special attention to detail and documentary aspects;

- Good ability to speak and write in both French and English;

 

Gesamtbewertung

3,8

Basierend auf 40 Bewertungen

2,8 Karriere / Weiterbildung
3,3 Gehalt / Sozialleistungen
3,5 Work-Life-Balance
3,0 Management

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