Ref: 12449 – Quality, Complaints & Vigilance Engineer

Manufacturing & Operations, Quality
Yorkshire
Posted 3 weeks ago

Salary will not be prohibitive for the right candidate. Based Yorkshire

Overview:

Market leading, Yorkshire based manufacturer of medical devices is currently experiencing growth, with requests to supply a more varied product range to a global customer base. Strategically this means that the business have to expand and grow their overall technical ability through the appointment of specialist staff with the Quality, Complaints and Vigilance Engineer being one of these recruits.

The Role:

The Quality, Complaints and Vigilance Engineer will support current medical device product lines for sale within Europe, in particular leading the customer complaints, vigilance and post market processes.

Responsibilities:

  • Ensure compliance to regulatory requirements appropriate to the Medical Devices Directive and ISO 9001.
  • Make sure that customer reported complaints are investigated adequately and that root cause findings and corrective action results are communicated to appropriate internal stakeholders.
  • Assist with the investigation, risk assessment and resolution of product quality issues.
  • Maintain the product Technical Files, including updating the Risk Management File and Clinical Evaluation following product quality issue investigations or design, process or regulatory changes.
  • Authorship of the Post Market Clinical Follow up Plan and coordination of the work to implement this.
  • Coordinate the validation of the effectiveness of proposed post market solutions and their implementation in the field with other departments as required and update the Technical File as appropriate.

The Person:

  • Proven experience in quality engineering related activities, from within a highly regulated industry i.e. Medical Device, Automotive or Aeronautical.
  • A strong working knowledge of quality processes such as: CAPA, Complaint Management, Risk Management, Root Cause Analysis and Non Conformance Reporting.
  • Experience in collating significant data and presenting it in clear formats to senior management.

The Opportunity:

At this moment the business is expanding into new markets and new territories that require its Quality, Regulatory and Compliance teams to expand and grow their overall technical ability. This therefore creates an exciting opportunity for people within these teams to expand their roles to become true technical experts within their field or alternatively to take their first step into a people management role.

Contact:

If you have the required background and experience and believe that you can make a true contribution to the organisation, then please contact us on 0113 4142782 or by email applications@airtonsolutions.co.uk for an exploratory conversation, quoting the vacancy reference number.

Airton Solutions is a recognised brand within the manufacturing and engineering sector. Based from Leeds we operate within the UK and internationally providing both clients and candidates with unrivalled levels of knowledge and customer service. Both Airton Solutions and its clients promote a policy of equal opportunities. Our policy is to treat job applicants and employees in the same way regardless of age, gender, marital status, sexual orientation, race, ethnic origin, religion, colour or disability.

Key words: Medical Device, Design Control, R & D Engineer, Development Engineer, Class III, Class 3, Class III, Class II, Class 2, Validation, Verification, DHF, Design History File, Design Dossier, Graduate, Medical, Regulatory Affairs, Quality Assurance, Quality Contro

Job Features

Job CategoryMedical Devices, Metals

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