Quality Assurance Engineer Medical Devices

Posted 4 April by Phagenesis Limited

The position reports to the Head of Quality and Regulatory Affairs and involves both quality assurance activities e.g., supplier management and development of the QMS system, and quality control activities e.g., product inspection and release.

Day to day responsibilities will include:

  • Supplier Management (SCARs, KPIs, Supplier Assessments, Supplier Agreements)
  • Non-Conformances
  • Customer complaints
  • Product inspection and release
  • Contribution to the development of new QMS procedures
  • Involvement in Management Reviews
  • Tracking and trending QMS KPIs
  • Internal and external audits
  • General quality administration support

The successful candidate must have

  • Experience of working in a quality team within a medical device company
  • A quality qualification or relevant time served experience

The successful candidate should have

  • At least 3 years experience as a quality professional in a medical device company
  • A familiarity with operating to ISO13485 compliant processes and procedures
  • A track record in supplier evaluation and monitoring
  • Experience of product inspection and release
  • Familiarity with management of customer complaints and Non-Conformances
  • The ability to prepare for and present at QMS meetings
  • A positive enthusiastic approach and excellent communication and interaction skills
  • Experience of working within a QARA team environment, provide support to other departments (Customer Services, Clinical, R&D, Sales & Marketing)
  • The capacity to work independently with minimal supervision
  • Good reporting skills and excellent computer literacy

Phagenesis offer a competitive remuneration package in a fast-moving dynamic company marketing novel neurostimulation devices for the treatment of swallowing dysfunction (dysphagia). We are world leaders in dysphagia treatment and want a dedicated enthusiastic quality engineer to round out our quality team to keep us there.

We will be reviewing applications from 16th April so please apply by 13th April to ensure that your application will be considered.

Required skills

  • Complaints
  • Inspection
  • Quality Assurance
  • Quality Control
  • Supplier Evaluation

Application question

Do you have experience of working in a medical device company?

Reference: 34820784

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