Quality Assurance 13485
Our client based in Bridgend is looking to appoint an QA. The primary job responsibility is auditing Quality Systems and processes for compliance to the applicable company policies and procedures.
The successful applicant must have basic knowledge of manufacturing processes and an ability to work towards a thorough knowledge of our client's processes and products.
- Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews with employees for compliance.
- Follow-up and support resolution of audit findings by seeking appropriate corrective actions.
- Track implementation of corrective actions and verify actions for effectiveness.
- Support internal and external audits to demonstrate compliance with ISO13485, 21 CFR Part 820, plus other related external standards as required, including interfacing with regulatory agencies if necessary.
- Develop and maintain department procedures and implement ongoing improvements.
Assist in achieving other regulatory objectives (e.g., QSR training, Quality Program applications) at the direction of the Senior Compliance Specialist.
- Must develop a thorough knowledge of QSR regulations, ISO13485 guidelines, MDD, CMDR MDSAP
- Ability to work on your own initiative with minimum direction.
- Clear verbal and written communication.
- Ability to organise information effectively, prioritizing tasks according to their urgency and importance.
- Must be able to manage stressful situations and to handle controversial issues; firmly adhering to the principles of the regulations and guidelines.
- 3-5 years of audit experience required.
- Lead auditor qualification ISO13485 preferred.
- Internal auditor qualification essential
- Experience of problem solving to correct issues impacting compliance are essential.
- Experience of working to ISO13485 & 21 CFR Part 820 is essential
Company offer a great working atmosphere, car parking on site and canteen.
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