Wird geladen...

Design Quality Engineer – Le Noirmont | JobRevolt

Über den Job

Bien-Air Surgery develops, manufactures and markets high-tech instruments for microsurgery and has held a strong international market position thanks to emphasis on invention, innovation, and product quality. To support growth, they are adding to their team at the Bienne site to participate in the development of Medical Devices.

Aufgaben

Lead and support New Product Development (NPD) and Design Changes by ensuring compliance of activities and documentation to internal QMS requirements as well as to external regulations and standards (FDA, ISO)
Support Verification & Validation activities to ensure compliance with applicable Design Control requirements
Generate and maintain Risk Management during NPD and Design Changes using principles from ISO 14971
Ensure quality assurance according to principles of Design Changes of medical devices during all stages of product development
Update existing product documentation in compliance with requirements of MDR
Create, review or approve DMR and DHF documentation released during NPD and Design Changes
Contribute to generate and maintain User Information Material
Contribute to continuous improvement of internal procedures related to NPD, Design Change and Risk Management
Become key contributor to product reprocessing methodology and testing (cleaning and sterilization)

Profil

At least Bachelor's Degree in mechanical, micro-mechanical or biomedical engineering
1 to 3 years' experience in quality assurance of medical devices, ideally class IIa or above
Demonstrated knowledge of DMR and DHF structure and contents
Experience with ISO 13485 QMS and Risk Management for Medical Devices
Experience with EU MDR 2017/745
Computer skills: MS-Office suite, ideally PLM system
Fluent in French, with good knowledge of English (level B2 or higher)
Strong organizational and follow-up skills, attention to detail
Open-minded personality with ability to quickly integrate a team

Rahmenbedingungen

Ort: Bienne, Rue de l'Ouest 2b, 2340 Le Noirmont
Kontakt: Rue de l'Ouest 2b, 2340 Le Noirmont

Benefits

Supportive and collaborative work environment within a family-oriented company structure
Opportunity to join an innovative and fast-growing industrial SME
Role with real impact on the company's performance and results
Opportunities for continuous learning and ongoing professional development

Design Quality Engineer

Über den Job

Über den Job

Aufgaben

Profil

Rahmenbedingungen

Benefits

Skills

Weitere offene Stellen