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Position: Quality Engineer (Medical Devices)
Location: Gloucester, Gloucestershire
Job Type: Permanent / Onsite

My client, a global manufacturing business are on the hunt for a Quality Engineer to support all quality processes throughout the business.

Role and Responsibilities – Quality Engineer (Medical Devices)
In this role, you will be responsible for supporting and maintaining the effectiveness of the businesses QMS in accordance with ISO 13485. This will be achieved through product and process compliance through effective management of all quality activities.

Other responsibilities include:

Maintain compliance with ISO 13485, MDR and applicable regulatory requirements
Improve CAPA effectiveness and closure timeliness
Analyse quality data and trends to identify improvement opportunities
Develop, review and update quality procedures, work instructions and records.
Experience or Qualifications – Quality Engineer (Medical Devices)

Degree educated in a relevant subject associated to engineering, medical technology or equivalent
Knowledge of ISO 13485 Quality System and FDA Quality System requirements essential
Experience of Quality Tools including 8D, CAPA, 5 Why, PCDA and 5S
CAPA, non conformances, change control and complaint investigation experience
Benefits – Quality Engineer (Medical Devices)

25 Days + Bank Holidays
Private Health Care Options
Competitive pension contribution
Employee benefits platform for retail discounts
Candidates who currently are a Quality Engineer, QMS Engineer, Quality Assurance Engineer, Validation Engineer or Medical Device Quality Engineermay be suitable for this position.

For more information regarding this Quality Engineer (Medical Devices) role please contact Ben Herd on (phone number removed) or

Omega Resource Group is acting as an Employment Agency in relation to this vacancy.

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Omega is acting as an Employment Agency in relation to this vacancy. Omega does not charge candidates any recruitment or job‑seeking fees at any stage of the hiring process