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Medical Device Quality Manager jobs

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    • Managing key relationships: working closely with customers, suppliers and internal stakeholders to keep quality system compliance on track, and maintaining…
    • Previous Quality Inspection experience within a regulated manufacturing environment, such as medical devices, aerospace, automotive or precision engineering.
    • Qualifications in project management or quality improvement.
    • A minimum of 5 years’ post-registration, ideally within leadership or quality roles.
    • Drive clinical quality and performance, supporting the achievement of quality, productivity and TPL targets.
    • We’re seeking an experienced and motivated Clinical…
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    • Managing regulatory documentation and technical files for medical device submissions.
    • Involvement in supporting the compliance and lifecycle management of Class…
    • Manage the medical quality operational and capital expenditure in line with budgets and business plans.
    • Through leading by example, ensure that the quality…
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    • Domain: Class III medical device · regulatory affairs.
    • 3–7 years' experience in regulatory affairs, quality assurance or related compliance roles within medical…
    • Liaising with clients on quality issues to ensure outcomes are satisfactory, maintaining strong working relationships throughout.
    • ISO 9001: 5 years (preferred).
  • View similar jobs with this employer
    • Knowledge of medical device regulations and standards.
    • Lead the development and maintenance of Product Risk Management documentation for new and existing…
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    • Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
    • Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
    • Gain exposure to a newly launched medical device.
    • A strong understanding of medical device regulations and quality management systems (ISO 13485/MDR desirable),…
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    • Domain: Class III medical device · Validation and quality assurance.
    • Experience with system validation, testing or quality assurance in a medical device or…
    • Experience leading validation projects within a medical device manufacturing environment.
    • Opportunity to work on regulated, high-impact medical device products.
  • View similar jobs with this employer
    • Domain: Class III medical device · validation and compliance.
    • Demonstrated experience with ISO 13485 and IEC 62304 in a medical device or comparable regulated…

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Job Post Details

QMS Manager - job post

Fortem People
Keighley
£50,000 - £55,000 a year - Permanent, Full-time

Job details

Pay

  • £50,000 - £55,000 a year

Job type

  • Permanent
  • Full-time

Location

Keighley

Benefits

Pulled from the full job description

  • Free parking
  • Company pension
  • On-site parking

Full job description

QMS Manager: Quality & Compliance West Yorkshire | £50,000 to £55,000 | Full time | Own the Quality Management System for a well established precision engineering business

Take true ownership of a Quality Management System that matters

Fortem People is recruiting on behalf of a well established, multi sector engineering business in West Yorkshire, on a confidential basis. This is a newly elevated role, previously positioned as a Supervisor post but reshaped to reflect the seniority and scope it genuinely carries. You'll be the subject matter expert for the entire Quality Management System, trusted to lead audit strategy, mentor internal auditors and keep certifications watertight across a demanding, multi standard environment.

What you'll be doing

  • Owning the QMS end to end: verifying, checking and maintaining IATF16949 and AS9100 system compliance across the business
  • Leading the audit programme: creating and executing audit plans, managing internal and external audit requirements and driving corrective actions through to close
  • Developing people: training and mentoring internal auditors, building audit capability across the team
  • Driving improvement: leading kaizen events in response to audit findings and maintaining procedures and work instructions within the QMS
  • Managing key relationships: working closely with customers, suppliers and internal stakeholders to keep quality system compliance on track, and maintaining the lessons learned database and quality records library

You'll report to the Quality Manager.

Who we're looking for

  • Significant working knowledge of IATF16949 is essential, this is non negotiable for the role
  • AS9100D experience alongside this would be a real advantage
  • Lead Auditor qualification (or equivalent significant audit experience)
  • Confident using standard problem solving tools (8D, 5 Why, Ishikawa, RCA)
  • Proficient in Excel, with data analysis tools like Minitab or Power BI a plus
  • A natural leader and communicator, comfortable influencing across all levels of the business

It would also be great (but not essential) if you've got practical experience of NADCAP or PED requirements, or hold Chartered Quality Institute membership with an active CPD profile, but our client is just as focused on finding the right calibre of person as the perfect certificate list.

Why this role?

  • £50,000 to £55,000, reflecting the true seniority of the role
  • A newly reshaped position with real scope to lead and shape quality strategy
  • Multi sector exposure across a genuinely varied, technically demanding business
  • A business that trains, mentors and invests in its people

How to apply

This role is being handled exclusively and confidentially by Fortem People. For a discreet, no obligation conversation, contact Rachel Deeks at Fortem People (rachel@fortempeople.co.uk) or visit www.fortempeople.co.uk.

All applications will be treated in the strictest confidence. Fortem People is acting as an employment agency in relation to this vacancy.

Pay: £50,000.00-£55,000.00 per year

Benefits:

  • Company pension
  • Free parking
  • On-site parking

Work Location: In person

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