Senior Quality Engineer

TN United Kingdom; West of England; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Senior Quality Engineer to join their medical division in Gloucestershire. This role involves providing crucial Quality Engineering support for innovative medical devices, including drug delivery systems and surgical planning software. The ideal candidate will have extensive experience in quality assurance within the medical device sector, ensuring compliance with regulatory standards while driving process improvements. With a focus on collaboration, you will work closely with development and manufacturing teams, contributing to the success of cutting-edge projects. The company offers a competitive benefits package and promotes a healthy work-life balance through flexible working arrangements.

Benefits

9% Non-contributory Pension

Discretionary Bonus

Subsidized Onsite Restaurants

Free Parking

Car Sharing Scheme

24-hour Fitness Centers

Flexible Hours

25 Days Holiday Plus Bank Holidays

Life Assurance

Cycle-to-Work Scheme

Qualifications

• 5+ years of experience in Medical Device Quality Engineering.
• In-depth knowledge of ISO standards and risk management tools.
• Experience with NPI processes and change control.

Responsibilities

• Collaborate with teams to ensure products meet requirements.
• Support validation and generate necessary documentation.
• Identify and implement process improvements.

Skills

ISO 13485

21 CFR Part 820 QSR

Risk Management

Change Control

Validation Activities

Collaboration Skills

Attention to Detail

Communication Skills

Process Improvement

Education

Degree in Life Sciences

Engineering Degree

Medical Field Degree

Tools

Quality Tools and Statistics

ISO 13485 Auditor Training

Job description

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A vacancy has arisen for an experienced Senior Quality Engineer working within the medical division based in Charfield, Gloucestershire.

The successful candidate will be responsible for providing Quality Engineering support for manufactured or subcontract manufactured current and development products. These include a drug delivery system (neuroinfuse), surgical planning software (neuroinspire), and devices supporting neurosurgery.

Key tasks will include reviewing and/or generating requirements and specifications, validation protocols/reports, risk management and design change documentation, as well as CAPA and non-conformity support.

The candidate will need to work closely with development and manufacturing teams based in Gloucestershire and Swords (Ireland). Some travel is required, and on-site presence is expected at a minimum of 3 days a week.

Responsibilities

1. Collaborate with project team members in new product development and design change activities to ensure products meet requirements and regulations.
2. Support validation and risk management activities and generate documents required for the Design History Files.
3. Review and approve change control records.
4. Provide Quality Engineering support for non-conformities and CAPAs.
5. Identify and implement process improvements.
6. Assist the Quality Manager as needed.

Key requirements

• In-depth knowledge of ISO 13485 and 21 CFR Part 820 QSR.
• 5+ years of experience in a Medical Device Quality Engineering role.
• Experience with Risk Management tools and techniques per ISO 14971.
• Experience working in a design and development project team.
• Knowledge of change control processes.
• Understanding of validation activities.
• Ability to understand hardware and software requirements and specifications.
• Strong collaboration skills and stakeholder awareness.
• Excellent communication skills and attention to detail.
• Degree in life sciences, engineering, medical field, or equivalent experience.
• Knowledge of quality tools and statistics.
• Experience with neurological or drug delivery devices is preferred.
• Experience with NPI processes.
• Knowledge of injection and extrusion moulding processes.
• Training as an internal or lead auditor for ISO 13485.
• Knowledge of IEC 60601 standards.

The ideal candidate should be

• Organized and self-motivated.
• Detail-oriented with excellent communication skills.
• Open to change and adaptable.
• A team player with a focus on quality.
• Capable of working under strict deadlines and motivating others.

Travel to subsidiary sites and suppliers will be required. The role balances individual initiative with team collaboration.

Joining Renishaw offers career development opportunities, a competitive benefits package—including a 9% non-contributory pension, discretionary bonus, subsidized onsite restaurants and coffee shops, free parking, car sharing scheme, and 24-hour fitness centers (availability varies by site). We promote a healthy work-life balance with a hybrid working policy, flexible hours, 25 days holiday plus bank holidays, life assurance, cycle-to-work scheme, enhanced maternity pay, health cash plan, BUPA health trust, and employee assistance programs.

Further information about our benefits, diversity, and inclusion can be found on our website.