Site Operations Manager Wiltshire Medical Devices IndustrySRG are working with a leading worldwide Medical Device manufacturer based within the Healthcare, Electronics and Industrial markets. Our...
Quality Assurance / Regulatory Affairs Manager - Marlborough - Medical Devices Industry
SRG are working with a leading worldwide Medical Device manufacturer based within the Healthcare, Electronics and Industrial markets. Our client is recruiting for a Quality Assurance/ Regulatory Affairs Manager to lead and co-ordinate the quality and regulatory activities of the team.
- Manage all of the Quality control activities- Design and facilitate Internal Audit programmes to cover ISO13485 / GMP- Implement and maintain ISO13485 / GMP / FDA / Medical device standards in R&D, QA and Process areas- Lead the documentation, reviews and approval of customer specifications - Reporting Quality KPIs and managing them effectively- Ensuring incoming goods are meeting quality specifications- Liaise with customers and suppliers to rectify any quality problems- Lead customer complaint reports and carry out action plans- Ensure bio-burden and pest-controls are compliant- Represent other sites in second and third-party audits - Support the development of new products
Essential Qualifications: - A minimum of 5 years relevant experience within the regulatory affairs discipline, including Medical Device, Biotechnology, and/or Pharmaceutical experience. - Preferably degree qualified or experience gained in a medical manufacturing facility. - Certification as an Auditor in the area of ISO 13485 standards would be advantageous.
Essential Experience: - Knowledge of the requirements, global Regulatory and Quality requirements for the manufacturer and marketing of drugs and medical devices - Quality Assurance Leadership experience in a medical manufacturing facility- Knowledge of Quality systems and manufacturing processes in medical device and pharma industries - Demonstrated experience interfacing with FDA/Regulatory inspectors and customers during customer audits
Additional desirable skills, experience and qualifications: - Good Laboratory Practices (21 CFR Part 58)- Bioburden, Biocompatibility, and Microbiological Testing - ISO 13485 Audit - Lean/Six Sigma - FDA 510K Submissions - Recall Experience - Medical and Manufacturing Experience
If interested and qualified to carry out the above position, please send an updated CV or call 0161 8682233 for more information.
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.