QA Specialist - Medical Devices
An exciting opportunity has arisen for a QA Specialist to focus specifically on Medical Devices. The role based in Iceland is great chance to build your portfolio with a leading pharmaceutical company.
- Drive simplification & standardization of the QMS in line with overall quality strategies & initiatives
- Establish international and regional /local relationships with RA, other QA Groups, Manufacturing, Development and Management
- Ensure continuous regulatory knowledge as necessary for the business.
- Host and manage site audits
- Manage relationship with health authorities
- Maintain oversight of customer feedback and post marketing activities (e.g. complaints, FSCAs, recalls)
- Maintain oversight of supplier monitoring program
- Perform internal and external audits
- Maintain oversight of training program
- Record and manage quality issues, escalating serious events to senior management
- Lead Medical Device management review process and quality planning
- Lead and/or participate in quality/compliance/regulatory projects
Skills and Requirements
- Bachelor's 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
- 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
In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.