Medical Devices – Quality Assurance Officer

Job Specification

Quality Assurance Officer – Medical Devices
Salary £28,000 – £35,000 per annum + up to £3,000 Discretionary Bonus
Hours: Monday – Friday 9:00am – 5:00pm
Location: Head Office based in Walsall, West Midlands.

We are a fast-growing private healthcare company and due to rapid product expansion, we are recruiting an experienced Quality Assurance Officer for Medical Devices to join our Regulatory team.

This is a fantastic opportunity for a motivated individual as this job offers variety of working in a quality role but also being involved in regulatory work. As a small but growing company with an expanding pipeline of products you most certainly won’t be bored.

Reporting directly to the Regulatory Manager you will be responsible for supporting the day to day management of the QMS to ISO 13485:2016 along with continuous improvement to the existing system.

Key responsibilities include:

  • Transfer from MDD to MDR
  • Updating and writing SOP’s, risk management files, post market surveillance documents and clinical evaluation reports;
  • Raising CAPA’s, change controls, Non- conformances, Supplier Corrective Actions (SCARs) and providing resolution where applicable to support maintenance of certification/ standards;
  • Reviewing and approving validation documents and Product Quality Reviews reports (PQR’s);
  • Compliance to applicable medical device regulations and standards, including the MDR requirements;
  • Compliance to GDP; and
  • Proof reading and approval of product labels

Key requirements:

  • Degree in Life Sciences.
  • Significant and demonstrable experience of working in a similar Quality Assurance related role within the Pharmaceutical Industry.
  • Excellent working knowledge of ISO 13485: 2016, MDD and MDR 2017/745.
  • Excellent oral and written communication skills and ability to present at different levels of the organisation.
  • Strong interpersonal skills with the ability to work cross functionally across the business, with suppliers and customers,
  • Excellent attention to detail and the ability to work to tight and challenging targets and deadlines.

The full role profile is available here. Quality Assurance Officer – Medical Devices

The successful candidate must have a strong medical device background and be able to work in a busy, diverse and demanding environment.

We are seeking a passionate individual who has a real hunger to succeed. You will have first class professional skills and strong business insights. You will need to be a real people person, who has the confidence to quickly engage in conversation with a wide range of people, negotiate and influence situations to deliver great results.

At Fontus Health we keep people at the heart of everything we do and pride ourselves on our integrity and values. We offer a competitive salary and great benefits package.

Please forward your CV and covering letter including salary expectation to

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