Quality Engineer

Zoek Pin Winchester, Hampshire, England

£27000 - £36000/annum

Permanent (Full time)

Posted 7 days ago

Quality Engineer, Hampshire, Competitive Salary dependant on experience

Blackfield Associates are supporting a world leading Medical Device manufacturing organisation, based in the Hampshire area, in the search for a Quality Engineer. This is to join their team on a permanent basis.

The core function of the role will be to ensure that the introduction of all new projects within the business meet the requirement of the company Quality Management System (QMS). This will include taking products from R&D and conceptualising this in manufacturing. Previous Process Validation experience is essential for applicants.

As part of a multi-skilled team, the successful Quality Engineer will act as a key contact for quality and compliance activities, in ensuring best practice and adherence is adopted throughout the manufacturing process.

Other responsibilities of the role will include:

Involvement in project teams in the development and introduction of new products/processes
Working with said teams in ensuring compliance to the QMS throughout
Conducting validation activities in the planning and preparation of projects
Supporting training in the company's validation/risk management activities
Involvement in the planning and preparation of engineering change orders
Carry out risk management activitiesIn order to be considered candidates must be technically sound in Quality Systems and as such have a solid foundation and experience with GMP. In addition to this, it is important individuals have experience working within a similar process manufacturing environment, in a quality department. ISO13485 experience would be highly advantageous. Candidates would also ideally be educated to Degree Level within a relevant Engineering/Scientific Discipline.

It would be advantageous to have experience in any of the following areas: FDA Quality System regulation, ISO14971, Six Sigma, project management, continuous improvement, root cause, CAPAs.

This is an excellent opportunity for a Quality Engineer to join a rapidly expanding and innovative organisation offering salary an excellent salary which is flexible for the right individual, plus 25 days holiday, Pension Scheme and Healthcare.

This role is based in Hampshire and commutable from, Portsmouth, Fareham, Gosport, Southampton, Havant, Alton, Winchester, Basingstoke, Andover, Salisbury.

To apply, please email your CV to

STR Limited is acting as an Employment Agency in relation to this vacancy

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