QARA Manager

Here at SRG, we partner with one of the longest and most reputable manufacturers of surgical instruments and medical devices in the UK. They are looking for a QARA manager to join their site in Manchester.

As the QARA Manager, you will be responsible for ensuring the business remains compliant to internationally recognised standards and regulatory obligations as required by a medical device organisation. You will be the designated site Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC). Some of your main duties and responsibilities will include:

• Maintain the QMS in compliance with all relevant standards identified as a requirement for the organisation.
• Maintain and produce technical documentation across of product ranges in line with MDD93/42/EEC and EU MDR 2017/745.
• Conduct external assessment processes to maintain relevant certifications and liaise with external quality and regulatory authorities as required.
• Host management reviews, report metrics on current QA activities, and identify QMS improvements as required.
• Liaise with other business functions as required in order the implement new processes.
• Participate in various projects giving input on regulatory and quality aspects, taking compliance, verification and validation, and risk management into consideration.
• Perform internal audits as required.
• Identify, monitor, and support the implementation of non-conformities, corrective and preventative actions, and reported complaint/incidents.

As the ideal candidate, you will be educated to degree level or equivalent experience in life science discipline. You will have at least 5 years' experience working within a QARA role in the medical device industry. It is essential you have working knowledge of ISO 13485 and ISO 14971, MDD to MDR transition and experience of producing technical documentation for class I, class IIa medical device. You must have an internal auditing qualification.