Quality Assurance Officer

Location: North Yorkshire  |  North Yorkshire  |  England
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHQAO
Salary: £25000 - £35000
Job Status: Permanent / Full Time

I am currently looking for a suitably experienced Quality Assurance Officer, with the energy and drive to implement quality improvement & regulatory compliance across my clients business.  I would need a self-starter who can schedule and plan their own work. A working knowledge of quality management standards in a regulated environment would be beneficial (e.g. ISO13485 / ISO9001 quality management systems

Quality / Regulatory

Implementation and maintenance of ISO13485 / ISO9001 quality management system

Internal / supplier audits

Handling & disposition of product – process nonconformity

Measurement, analysis & improvement including corrective and preventive actions

Maintenance & update of quality documentation (Specifications / Procedures)

Product – process qualification/validation and the writing of suitable protocol & test reports.

Complaint handling & investigation.  Medical device vigilance procedures.

Product release.

Preparing quality data for the management team.

Primary contact / liaison with regulatory authorities

Maintenance of Medical Device Files

Quality review of specifications & reports

General support documentation for our sales team and distributors.

REQUIRED COMPETENCIES

A minimum of 2 years’ experience working in the medical device sector or similar regulated industry.

A good standard of education (A-levels or equivalent).

Capable of preparing, reviewing and maintaining quality documentation and records.

Some travel will be required to fulfil the role.

The company is looking to pay £25,000 up to £30,000 pension and health insurance package