Newton, United Kingdom
$115,000 - $140,000
5 months ago
Catalyst Life Sciences have been engaged in the search of a Senior Quality Manager to join a fast growing Medical Devices organization commercializing their orthopaedic device used in treating musculoskeletal diseases that has recently received 510(k) clearance.
- Lead overall quality management system (QMS) execution to ensure compliance with cGMP, regulatory agencies, client and corporate expectations.
- Work closely with Contract Manufacturing Organisations (CMOs) to ensure all suppliers on the ASL adhere to FDA and ISO13485 standards through regular contact and audits.
- Develop and maintain system for monitoring quality metrics, including post market surveillance activities.
- Lead and supervise a small team of a Document Control Specialist and Quality Specialist.
- Provide quality system performance reports to management and develop and maintain Customer Complaint System.
- Work collaboratively with the VP Quality for the company's US operations, as well as cross functionality responsibilities with the global team.
- Work autonomously with the entire QMS, being the point of contact for deviations, CAPA implementations, change controls, SOPS.
- Bachelor's in a Science, Engineering, or relevant field.
- 8 years' experience in a Quality focused position in the Medical Devices industry under ISO:13485 and FDA guidelines.
- Experience working with orthopaedic devices is a must.
- Prior exposure to working in a start up / small company environment (<100 people)
- Ability to work both autonomously and collaboratively in a small company environment.
- US Citizen or Green Card holder.