Quality Expert with Medical Devices
CK QLS are recruiting for a Quality Expert for Medical Devices to join a leading medical device company at their site based in Basel on a on a contract basis for 6 months, with the possibility of extension.
This company is a global pharmaceutical and medical device company, developing innovative medicines for a variety of healthcare issues.
This Quality Expert role will be based at our clients site based in Basel.
Quality Expert will be responsible for:· Ensuring technical development and manufacturing operations of assigned Medical Devices/Combination Products are conducted in accordance with company's Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency.
- Writing, Reviewing and approving deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
- Supporting Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients.
- Managing quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
- Performing or supporting inspections and audits as required.
- Writing/contributing to internal compliance policy and/or comment to regulations.
- Relevant qualifications in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science.
- Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines.
- English fluent in speaking / writing, German and/or French desirable.
- Good knowledge of medical device development and life-cycle management.
For more information or to apply for this Quality Expert within Medical Devices, please contact Jocelyn on 0041 (0) 782516595 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47606 in all correspondence.