Job Description
Have you got a background in Quality Assurance and are looking for the next step? We have an exciting opportunity to join a well-established, prestigious healthcare company in Romsey who are looking for a Quality Assurance Engineer to join their team.
This is a great opportunity to join a rapidly growing firm with an excellent reputation.
As a Quality Assurance Engineer you will 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.
As a Quality Assurance Engineer you will:
Maintain the Quality Management System certified to ISO 13485, ISO 14001, and MDSAP as required.
Perform Quality Management System internal audits, supplier audits, and environmental audits (as required). Compiling audit reports for management review.
You will Maintain the Document Control System as required
Carry 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.
Experience & Skills
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.
If this role sounds like you, please click APPLY NOW or call 07734595170 for more details.
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