Quality Assurance Engineer

Are you looking for an exciting new opportunity as a Quality Assurance Engineer/ Technician and looking to join an award winning national company that can boast 'Investors in People Gold' status? If so, we'd like to hear from you.

This is a great opportunity to join a rapidly growing firm with an excellent reputation. The company in question is expanding rapidly and serves the healthcare industry all over the country.

The main purpose of this role will be to maintain the Quality Management System certified to ISO 13485, ISO 14001 and MDSAP in compliance with applicable standards, legislation and directives, and ensure devices designed, manufactured and distributed are safe and effective throughout the product lifecycle.

Key Responsibilities …

• Maintaining the Quality Management System certified to ISO 13485, ISO 14001, and MDSAP as required.
• Performing Quality Management System internal audits, supplier audits, and environmental audits (as required). Compiling audit reports for management review.
• Maintaining the Document Control System as required
• Carrying out non-conformance and CAPA investigations, and compiling comprehensive reports as required.
• Providing training to employees in the quality management business management system procedures and processes when required.
• Taking part in external notified body audits and testing-house product quarterly inspections.

In order to be successful in the position you will need …

• Proven experience in maintaining a Quality Management System certified to ISO 13485.
• A working knowledge of the Medical Devices Directive 93/42/EEC
• Qualified to perform Internal Audits to ISO 13485 and (with training) to ISO 14001.
• Previous experience in using and maintaining a document control system.

Vibe Recruit is acting as an Employment Agency in relation to this vacancy.