science, engineering & technology recruitment

Senior QA Officer

Location: Newcastle upon Tyne
Salary: Competitive
Status: Permanent
Ref: TKSenQAa

Senior QA Officer

An exciting opportunity has arisen for an experienced Senior QA Officer to join a life science company at their site in Newcastle on a permanent basis. The Senior QA Officer will be responsible for planning, organizing and conducting duties related to the site quality system.

You may be asked to lead small projects with manageable risks and resource requirements.

The main responsibility of this role is to establish and maintain the site quality system to meet all applicable requirements for medical device/IVD business, and everything that involves, including:

Audits

Non conformances

CAPA

Validation

Batch release

Training

Quality agreements

Record management and document control

Supplier quality

Work with procurement on supplier quality standards, supplier quality agreements, metrics

Supplier audits

Ensure quality of incoming materials

Premarket QA / Design Assurance / R&D Quality

QA representative for Design Controls and Risk Management for new product development projects and device change initiatives

Support design quality assurance for cross-site project

You will work closely with Quality and Regulatory Affairs management in developing quality objectives, and establish and maintain strong relationships with internal and external stakeholders. Candidates will ideally be educated to degree level (or equivalent) in a relevant scientific discipline, and will have substantial experience with increasing responsibility in medical device Quality Assurance. Experience in the IVD field preferred, but not essential.

Apply with your CV now, and feel free to contact Tom Kirkpatrick at CY Partners for more information.

The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.

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