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    • Practical experience in a regulated quality environment, ideally medical devices.
    • A broad quality role offering the opportunity to develop further experience…
    • This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices.
    • Ensure compliance with relevant medical device standards and regulatory requirements.
    • Knowledge of standards such as ISO 14971, IEC 62304, and related medical…
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    • Supporting regulatory strategy development and submission planning for Class III medical devices.
    • Maintaining compliance with ISO 13485, IEC 62304 and relevant…
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    • Scope to develop deeper expertise in medical device regulation and compliance frameworks.
    • The opportunity to influence regulatory pathways for medical devices…
    • To assist the decontamination team with all aspects of reprocessing medical devices.
    • Assist with logistics for delivery & return of devices/test-kits.
    • Experience with Class III medical device regulatory affairs or equivalent compliance environment.
    • This is an opportunity to register your interest in future…
    • Experience of testing materials in a laboratory setting.
    • Build an extensive knowledge of raw materials used in the manufacturing of medical products.
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    • Conducting system validation testing to verify that medical device systems meet defined requirements and regulatory standards.
    • Proven experience in a quality role within the food manufacturing, pharmaceutical or medical devices industry.
    • Have excellent attention to detail.
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    • Domain: Class III medical device · ISO 13485 · IEC 62304.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device validation.
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    • Experience with Class III medical device validation, testing or quality assurance.
    • Additional certifications in quality management or medical device compliance.
    • Support the Site Quality Manager with budgeting, monitoring and controlling medical QC expenditure.
    • Support the assurance that technical and cGMP standards of…
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    • Experience in system validation, testing or quality assurance within a medical device or regulated environment.
    • Strong analytical and problem-solving skills.
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    • Healthcare cashback plan for everyday medical costs, with private GP and health support services available.
    • You complete training as directed, follow all Health…

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Quality Control Officer
PRATAP PARTNERSHIP
Huddersfield HD8 0AP
•
Hybrid work
£32,000 - £35,000 a year
Permanent, Full-time
Apply now

Job details

£32,000 - £35,000 a year
Free parking, Company pension, On-site parking
Permanent, Full-time
Hybrid work in Huddersfield HD8 0AP

Full job description

Quality Control Officer - Medical Devices

Hybrid working model plus excellent benefits package

Must have relevant industry experience of or exposure to ISO 13485.

An established medical device business is looking for a Quality Lead to support the day-to-day operation of its Quality Management System and wider quality activity.

Working closely with the Quality Assurance Manager, this is a hands-on role covering QMS coordination, internal audits, CAPA, complaints, non-conformances and regulatory quality support.

Key responsibilities

  • Coordinate the day-to-day operation and continual improvement of the QMS
  • Coordinate the risk-based internal audit programme, including findings and corrective actions
  • Coordinate CAPA, complaints and non-conformances, including root cause and effectiveness reviews
  • Manage document control, quality records and quality metrics
  • Support compliance with ISO 13485 and MDSAP
  • Provide quality evidence and support to Regulatory Affairs
  • Coordinate supplier quality activity and monitor emerging quality risks
  • Support quality training and provide practical guidance to colleagues

Experience required

  • Practical experience in a regulated quality environment, ideally medical devices
  • Working knowledge of ISO 13485
  • Experience of CAPA, assisting in or preparing for internal audits, complaints, non-conformances and document control
  • Strong organisation skills with the ability to manage competing priorities
  • Confident reviewing information, identifying gaps and escalating quality issues
  • Relevant quality qualification, degree or equivalent experience preferred
  • Internal Auditor / Lead Auditor qualification desirable
  • Experience supervising or coaching colleagues desirable

The opportunity

A broad quality role offering the opportunity to develop further experience across QMS, auditing, CAPA, complaints and regulatory compliance within a medical device environment.

Pay: £32,000.00-£35,000.00 per year

Benefits:

  • Company pension
  • Free parking
  • On-site parking

Work Location: Hybrid remote in Huddersfield HD8 0AP

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