Quality Engineer

Staffline; Gloucester; On-site; GBP 36,000 - 48,000; Full time

Benefits offered by this job

25 Days + Bank Holidays

Private Health Care Options

Competitive pension contribution

Employee benefits platform for retail

Job summary

Omega Resource Group is seeking a Quality Engineer (Medical Devices) in Gloucester to support and maintain the effectiveness of the QMS aligned with ISO 13485. The role focuses on regulatory compliance, CAPA management and continuous improvement of quality processes.

The ideal candidate will hold an engineering degree, knowledge of ISO 13485 and FDA QSR, and experience with quality tools such as 8D, CAPA, 5 Why, PDCA and 5S. Onsite permanent role with benefits.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

Regulatory Compliance

Quality Tools

Data Analysis

Education

Engineering degree

Tools

8D

CAPA

5 Why

PCDA

5S

Job description

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 #removed# or #removed#

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

Omega Resource Group is an employment agency specialising in opportunities at all levels within the Engineering, Aerospace, Automotive, Electronics, Defence, Scientific, Oil & Gas, Construction and Manufacturing sectors.

For details of other opportunities available within your chosen field please visit our website #removed#