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Senior Quality Systems Engineer

Full Time
Job Sector:
Engineering / Technical, Manufacturing / Warehouse, Science / Analysis
South Wales
Salary description:
up to £38, 000
Start Date:
Petrie Recruitment
Job Ref:

Contract Type: Fixed Term, up to 14 month cover, for Maternity Cover

Salary: up to £38,000

Job Elements

·Please note there are options for employment status for this role, our clients will accept self-employed contractors or traditional PAYE.

·To be responsible for 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).

·Motivate and monitor performance of sub team to ensure departmental objectives are achieved in compliance with established quality procedures.

·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).

·Participate in the interpretation of Regulatory Requirements (ISO13485:2003, Medical Device Directive MDD 93/42/EEC and 21 CFR Part 820) to produce effective working policies and procedures.

·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

·Analyse data, including the use of statistical techniques, to provide reports to management to enable them to monitor system performance.

·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.

The ideal candidate will have:

·Diploma level Science/Engineering/Quality orientated qualification.

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

·Good analytical skills and experience of statistical techniques.

·Computer literate to include MS Word and Excel and MRP.

·Supervisory experience.

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

·Lean/ Six Sigma Green Belt.

·Certificate in Higher Quality Management.

·Internal Auditor Certificate to ISO: 13485.

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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