QA Post Market Survaillance
Location: Glasgow Scotland
Description: is looking of QA Post Market Survaillance right now, this job will be placed in Scotland. For complete informations about this job opportunity please give attention to these descriptions. Summary
An excellent permanent opportunity has arisen for a Post Market Surveillance Quality Assurance officer with a global leading medical device organisation based in Glasgow. This position off! ers and the post holder, a fantastic chance to progress their career by joining a global medical device organisation with and expansive portfolio of Class III medical device with many future products already in the pipeline for development. As such the team is rapidly expanding and will offer excellent long term career opportunities.
Key responsibilities and duties will include;
- Development of the companies Post Market Surveillance processes in compliance with MDD 93/42/EEC
- Development of effective feedback procedures, clearly defining roles and responsibilities for all inputs to PMS reviews and any actions resulting from these reviews
- Coordination of annual PMS reviews for all product platforms and escalation and resolution of any new or increased risks identified from these reviews
- Development of cross-functional and collaborative relationships within the facility, in particular with R&D, Clinical, RA and Manufacturing! Engineering
- In conjunction with QA Complaints group,! identifies all reportable issues and coordinates Adverse Event Reporting (AER), Medical Device Vigilance (MDV) and Medical Device Reporting (MDR) to Competent Authorities, the FDA and Notified Bodies
- Ensures timely communication of any AER, MDV, MDR reports and any follow-up reports.
- Liaises with internal constituents as required when MDV/AER/MDR issues arise
- Development of regular communications and reports to senior management, functional leaders, customers and regulatory bodies as required
- Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business
- Relevant Science/Engineering Degree or appropriate Clinical or Nursing experience
- Experience and/or training in Post Market Surveillance processes
- Extensive and proven experience in Quality Systems in a similar role within a medica! l device environment
- Experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing. Experience of Medical Device Directive and related regulations, preferably for Class III devices
- Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.
SRG, winners of the Recruitment Professional Awards 2011 'Best Company to work for' and 'Best People Development Business' awards, and the only "highly commended" company in the Annual Recruiter Awards for Excellence 2011, for 'Best Small Recruitment Agency to Work For'.
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This job starts available on: Thu, 13 Jun 2013 12:45:26 GMT