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Quality Assurance Engineer – Medical Devices – Hampshire – £35k neg.

Job Ref: JM 7687

Job Title: Quality Assurance Engineer – Medical Devices – Hampshire – £35k neg.

Salary: £35,000 neg.

Location: Hampshire – Southampton – Portsmouth – Basingstoke – Andover




This is a rare opportunity for a Quality Assurance Engineer to work for a dynamic medical device technology company developing products to enhance patient outcomes. Working in a close knit team you will have access to all key members of the development team. This position is a great opportunity to advance in to a senior Quality Manager position.

The Quality Assurance Engineer will assist in managing the QMS on a day to day basis. Other tasks include the administration of quality documentation plus supplier and internal auditing.

Key Tasks:

  • Participating in testing activities across the sub-disciplines of systems and Electronic engineering, the generation of test plans, test specifications and protocols, test execution logs, test reports and problem reports
  • Developing an understanding of systems under test; proposing and implementing test strategies that align with system architecture, risk analysis and available test tools
  • Working with engineering, regulatory and risk, commercial, operational and quality colleagues to develop the traceability between product requirements, design and test items
  • Raising Problem Reports and Non-conformity Reports to address product quality concerns and quality management system concerns

The Candidate

We are looking for QA Engineer professional with experience within medical device, pharmaceutical or biotechnology field. We will also consider a graduate candidate but only with relevant degrees and some hands on experience.

Experience in the following areas is required

  • HND/Degree level qualification from a science/engineering background
  • Maintenance of BS EN ISO 13485 Quality procedures and related records
  • Processing of Change Orders through to their completion
  • Follow up of corrective and preventative action plans raised from internal and external NCR’s
  • Experience of cleanrooms and electronic manufacturing
  • Knowledge of BS EN 62304, 21 CFR Part 820, ISO 14971, BS EN 62304
  • Full Driving Licence

The Ability to multitask, prioritise workload, maintain a cool professional approach and work well under pressure is essential as is an enthusiastic attitude towards work, with an eye for detail and have a quality minded approach with a mind-set that quality can make a difference and an ability to deal with any issues thoroughly

G2 Clinical and Professional Resourcing are specialist recruiters for a wide range of positions including clinical trials, R&D, Quality, Compliance, Regulatory Affairs, Project Management, Project Engineer, Manufacturing and Operational positions.

Region: South East

Salary: £35,000 + Benefits

Sector: CPR

Type: all

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