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Job Location | West Lothian |
Education | Not Mentioned |
Salary | Salary negotiable |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent, full-time or part-time |
Are you an experienced Quality Assurance Officer looking for a new job opportunityWe are currently looking for a Quality and Technical Officer to join a medical devices company based in the Central Belt of Scotland on a part time basis covering maternity leave.The role initially will be home based but once travel restrictions have lifted, you will be expected to be in the office 1 day a week.As the Quality and Technical Officer you will be responsible for maintaining the effectiveness of the Quality Management System to meet ISO 13485:2016 and 21CFR Part 820.KEY DUTIES AND RESPONSIBILITIES:Your duties as the Quality and Technical Officer will be varied however the key duties and responsibilities are as follows:1. You will be responsible for maintaining the document control register to ensure all documents are current, have correct approval status and their review date is maintained. You will also maintain the CAPA system to ensure that corrective and preventative action items are addressed.2. Your role as Quality and Technical Officer will also include assisting with internal audit program, ensuring the training matrix is up to date and maintained as well as maintain customer feedback / complaints log and co-ordinate actions.3. Additionally, you will be responsible for co-ordinating any regulatory updates as advised by the QA/RA consultant and provide information on the above activities to senior management to assist with the preparation of management review.ROLE REQUIREMENTS:To be successful in your application to this exciting opportunity as the Quality and Technical Officer we are looking to identify the following on your profile and past history:1. Relevant QMS administration experience is essential for this position. Experience with ISO 13485:2016 and 21CFR Part 820 is also required for the role of Quality and Technical officer.2. Practical experience in internal audits to ISO 13485 is also required. Any experience of reducing cost and improving efficiency would be highly advantageous. Key Words: Quality and Technical Officer | Quality Assurance | QMS | Medical Device | Life Science | Regulatory Affairs | ISO 13485 | ISO 9001 Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.