Description
If you like to improve yourself and use your technical skills in a global active and well known company, Real Staffing has the perfect opportunity for you.The company is one of the market leaders in medical devices for combined drug-devices as well it offers innovative and high quality products in life science.
For a project in the area of Geneva we are looking for a Quality Manager.
Requirements:
- Master, PhD or MD degree
- Experience with quality system acc. ISO13485 and 21 CFR 820
- Knowledge about regulations in medical devices, including US regulations
- Experience with combined drug devices acc 21 CFR 4
- Assertiveness and Team player
- English business fluent
Your key skills should involve:
- Programs should be developed and implemented to maintain the standard of quality for existing services and products
- Check and improve product, material components, operational quality by developing procedures/policies
- Working experience with the process of design control for medical devices
- Experience with drug-device combination and medical device regulations - US an EU
- Ensure compliance design control
- Risk management acc. ISO 14971 / IEC 62366
- CE mark approval
- Supplier qualification and audits
- Check and approve change control, deviation and CAPA
- Contact for the suppliers through meetings and document reviews
If you bring a specialisation in quality management, regulations and expertise in medical devices, I would be delighted to have a confidential discussion about your options for progression.
If this outstanding opportunity sounds interesting, do not hesitate to contact me for more details or send me your CV.
For more information on this or other opportunities contact Marco Heumann, at Real Staffing Group, Zürich