UK Quality Manager

Jonathan Lee Recruitment Product Eng
£40k pa + Pension, phc, flexible benefits
15 Sep 2017
19 Sep 2017
Contract Type
Full Time
UK Quality Manager
Medical Devices
Pension, PHC, Flexible Benefits

Our client is a leader in their field, an innovator, developer, manufacturer and supplier of specialty procedural packs and vascular access devices for use across a range of clinical departments.

The business has been providing exception and trusted products and services to the NHS for over 50 years and are proud to be British and Independent.

Reporting to the Group Quality and Regulatory Manager, you will be accountable for the implementation, development and continual compliance of the Quality Management System throughout the company, to ensure the best possible products and services are provided to their customers. Leading a team of 4 (2 Quality Engineers & 2 Quality Technicians) you will effectively communicate on all Quality related issues whilst providing Quality support for new and existing process development and validation within the Company.

The Role

- Monitor and review all company processes, in conjunction with the department manager/functional head in order to ensure that they continually conform to the relevant regulations and standards and that there is a process of continuous development.
- Carry out the duties and responsibilities as defined in ISO 9001, ISO14001 & ISO 13485.
- Perform the Required Duties of a GDP Responsible Person (RP)
- ensuring that a quality management system is implemented and maintained;
- focusing on the management of authorised activities and the accuracy and quality of records;
- ensuring that initial and continuous training programmes are implemented and maintained;
- coordinating and promptly performing any recall operations for medicinal products;
- ensuring that relevant customer complaints are dealt with effectively;
- ensuring that suppliers and customers are approved;
- approving any subcontracted activities which may impact on GDP;
- ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
- keeping appropriate records of any delegated duties;
- deciding on the final disposition of returned, rejected, recalled or falsified products;
- approving any returns to saleable stock;
- ensuring that any additional requirements imposed on certain products by national law are adhered to

**Full Job Spec Will Be Provided**

About You

- Certificated level in engineering, science or business related discipline
- Minimum 5 years' previous experience in Quality role, ideally with ISO 13485 (minimum), ISO 14001, minimum ISO 9001
- Broad knowledge of quality systems and procedures
- Certificated Auditor
- 21CFR Part 820 experience would be an advantage
- Good Manufacturing Practice (GMP) experience preferred

If you meet the above criteria and you are looking for your next challenge in this industry leading, innovative medical company, then apply online for consideration

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