Team Leader of QA
Summary: A leading medical devices manufacturer in Bedfordshire is now seeking their new team leader of Quality Assurance and Regulatory Affairs.
Description: Team Leader of QA & RA
A negotiable Salary is available depending on your own experience
A leading medical devices manufacturer in Bedfordshire is now seeking their new team leader of Quality Assurance and Regulatory Affairs.
The main responsibilities are: -
*Ensure a safe and clean working environment in your department
*Lead site quality activities and the site quality team in accordance with all policies and procedures
*Lead continuous improvement activities for the team in meeting customer quality requirements which will include the maintenance of Quality Assurance systems throughout the site
*Undertake internal and external audits to ISO9001/ISO13485 standards
*Lead and drive the Quality Management System to ensure the timely closure of Customer Complaints, Internal Non-conformances and Supplier non-conformances
*Facilitate reports and actions on internal and external customer complaints
*Monitor and report KPI's in line with the requirements of the business
*Assist with the reduction of wastage
*Ensuring incoming goods are conforming to their specification
*Make sure key raw material specifications are aligned to the customer specifications
*Represent the site in second and third party audits
Essential Skills, Experience and Qualifications:
*Previously worked as a Quality Assurance Supervision / Manager within Medical Device manufacturing
*Medical device knowledge of CE, FDA and GMP
*Risk Management in the area of ISO 14971
*Experience of EU product submissions, license renewals, and periodic updates and registrations to regulatory agencies (FDA and EU regulatory entities) for medical devices
*Technical file compilation
*Be a certified Auditor in the areas of ISO9001 and 13485
*A self motivated problem solver who can make decisions and has a keen eye for detail
*Great team player who can work on your own initiative
*Adopt a "can do" approach within your team
*Work under pressure to tight deadlines
*Be a Lead Auditor
*Lean / 6 Sigma qualification
*Good Laboratory Practices (21 CFR Part 58)
*Experience of Bioburden, Biocompatibility, and Microbiological Testing
*FDA 510K Submissions
*The manufacturing of adhesives
For more information and to apply for this position, please send your CV with a covering email to explain why you feel you should be considered for this post.
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iNTECH Recruitment Ltd are experts in the recruitment of technical staff within the Manufacturing and Engineering industry, this includes electronic, electrical and mechanical engineering disciplines. We act as both an employment agency for all permanent positions and as an employment business for temporary contract positions.
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Team Leader of QA