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Quality Systems Engineer

Full Time
Job Sector:
Engineering / Technical, Manufacturing / Warehouse, Science / Analysis
South Wales
Salary description:
Range: £24, 000 - £33, 000
Start Date:
Petrie Recruitment
Job Ref:

Contract Type: Permenant

Salary: Range: £24,000 - £33,000

Job Elements

·To provide support to the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP).

·Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR).

·Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485:2003, Medical Device Directive MDD 93/42/EEC and 21 CFR Part 820) and local quality standards.

·Provide effective solutions/advice to design and manufacturing teams on established procedures to ensure products are designed and developed and manufactured according to the requirements of the relevant regulations

·Review and authorise documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations and alignment with other related documentation.

·Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and/or effectivity whilst ensuring compliance with applicable regulations.

·Support and perform training throughout the company to maintain awareness of the Quality System requirements.

·Support and conduct internal and inter-company Quality System Audits in line with local and group objectives.

The ideal candidate will have:

·Minimum A level or equivalent in a Science/Engineering/Quality orientated qualification

·Minimum of 3 years’ experience working in a QA/QS environment within the medical device or pharmaceutical industry.

·Knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC

·Knowledge of FDA QSR Part 820

·Computer literate to include MS Word and Excel and MRP

·Knowledge of GMP and audits

·Ability to work with minimal supervision and use initiative.

·Good inter-personal skills and the ability to communicate well in English both written and orally.

·Good record/documentation skills.

·Works with integrity, customer focus, accountability and teamwork.

Petrie Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.

Company Description

Petrie Recruitment is a relatively small - but perfectly formed!! - business - and it provides staff for a wide range of (mainly permanent) job categories in several sectors, but does tend to focus on manufacturing and commercial positions, e.g. Engineering, General Management, Production Management, Logistics, Purchasing, H.R., Finance, I.T., Sales/Marketing and all aspects of Administration.

Closing Date:

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