QA Officer

Posted on Jan 22, 2019 by Anonymous

Knutsford, Cheshire United Kingdom
Health Care
Immediate Start
Annual Salary
QA Officer

Due to expansion, a fantastic opportunity has arisen to join a Global Medical Device company as a QA Officer.
As QA Officer, you will be expected to interpret and advise on the GMP's associated with Medical Device manufacturing/testing. To ensure that the manufacture / testing of products comply with the relevant international quality and regulatory standards ISO13485, FDA.

The responsibilities of the QA Officer:

• Product Release and Batch Review Processes - to support the batch documentation review process, including the release of sterile and non-sterile products, to make sure they reviewed in an efficient and timely manner.
• To review the monitoring and reporting of environmental monitoring, bioburden trends etc. ensuring it is all carried out in line with SOPs and paperwork correctly completed and filed away.
• Document Control
• Quality Systems
• Complaints - Coordinate and monitor all customer complaints to aid in the timely progression and closure of complaints.
• Control of Non-Conformances, deviations and CAPAs
• Audits - Manage and perform internal and external audits, including vendors and suppliers.

The successful candidate for the QA Officer role will have:

• Previous experience working as a QA Officer or QA Specialist in either a pharmaceutical or a medical device environment
• Good written and verbal skills and good interpersonal skills.
• Ability to perform audits - internally and externally
• Good knowledge of applicable legislation, ISO13485 cGMP, regulatory requirements (MDD 93/42/EEC, MHRA, FDA etc) and appropriate ISO standards

If you are an experienced QA Officer looking for a new challenge please apply now!

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

Reference: 615559100

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