Medical Device Quality Specialist
- Permanent
- Quality Assurance, Quality Engineer
This vacancy has now expired. Please see similar roles below...
Hobson Prior are currently working with a specialty biopharma organisation who are focused on the advancing and manufacturing biosimilar medicines. Our client is looking for a Medical Device Quality Specialist Manager to join them on a permanent basis.
Job Responsibilities:
- Host and manage site audits
- Manage relationship with health authorities
- Maintain oversight of customer feedback and post marketing activities
- Maintain oversight of supplier monitoring program
- Maintain oversight of training program
- Record and manage quality issues, escalating serious events to senior management
- Oversight and approval of corrective & preventive actions to mitigate potential or actual non‐compliance risk
- Lead Medical Device management review process and quality planning
- Lead and/or participate in quality/compliance/regulatory projects
Key Skills:
- Strong collaboration skills and ability to build partnerships internally and externally
- Experience of working directly with competent authorities
- Change management experience and influencing skills
- Track record of leading teams and driving results
Requirements:
- Excellent written and oral English communication skills
- Batchelors Degree education in Pharmaceuticals, Law, Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality/Regulatory leadership roles.
- 5 years experienced working with EU, FDA, ISO 13485, ISO 14971 and other global Medical Device regulations
Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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