Quality Assurance / QA Officer - Medical Device
My client is an exciting medical devices company that are leading the way in developing simple to use devices. They currently have requirements for a Senior Quality Assurance / QA Officer to join the team. You will be responsible for ensuring regulatory compliance of Quality Management System requirements in accordance with 93/42/EEC and ISO 13485:2003.
* Support management and leadership of the Quality Technical section.
* To develop QMS documentation to ensure it evolves in accordance with regulatory and business requirements.
* The focus of the role is to support quality systems to ensure the site remains compliant with current GMP requirements.
* Ensure Technical/Design History Files are effectively maintained and comply with current MDD and 21 CFR part 820 requirements, including but not limited to maintenance of Essential Requirements, Risk Management and Post Market Surveillance.
* Prepare and audit schedule and conduct audits in accordance with ISO 13485:2003, CFR 21 Part 820, ISO 9001:2008, and internal company procedures.
* You will be responsible that the approved supplier list is maintained; ensuring technical agreements are in place and maintained
* To manage and support the supplier management and the internal audit programmes, using Quality Risk Management principles
* To monitor the completion of CAPAs identified and closure of the audit report
* The role will also involve supporting validation activities and providing general compliance support to the site.
* Candidates will have a degree or equivalent qualification in a science based subject.
* Previous experience in a Quality Assurance role will be highly desirable.
* Experience in the Medical Device industry, working to 93/42/EEC and ISO 13485:2003 standards would be desirable.
* Previous experience in internal and external auditing, validation and operational support will be desirable.
* Ability to identify opportunities for process and operational improvements and implement appropriate changes to deliver these benefits.
* Has a passion for quality excellence.
Key Words: QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, CAPA, Quality Assurance, Technical/Design History Files, 93/42/EEC, ISO 13485:2003
Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.
- Quality Assurance
- Supplier Management
- Quality Risk Management
- ISO 13485:2003
- Quality Systems
- Technical/Design History Files