Quality Engineer

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

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