Quality Assurance Engineer

Owen Daniels are supporting a Leading Medical Business based in Wolverhampton in recruiting for a Quality Systems Engineer / Quality Assurance Engineer to join the team on a permanent basis.

Salary: £40,000 p.a. + Excellent Benefits + Training.

Leading medical devices manufacturing company dedicated to innovation, safety, and quality with the mission to produce life-enhancing products that meet the highest regulatory and industry standards. As they continue to grow, they are seeking a meticulous and detail-oriented Quality Systems Engineer / Quality Assurance Engineer to join the team.

Job Overview:

The Quality Systems Engineer / Quality Assurance Engineer will be responsible for ensuring compliance with internal quality processes, regulatory requirements, and industry standards. You will conduct audits, identify areas for improvement, and work closely with cross-functional teams to maintain the highest quality standards in our production processes.

Key Responsibilities:

1. Conduct internal audits of manufacturing processes, documentation, and quality control systems to ensure compliance with ISO 13485, FDA regulations, and other applicable standards.
2. Prepare and maintain audit reports, documenting findings, non-conformances, and corrective actions.
3. Work with quality and production teams to implement corrective and preventive actions (CAPAs) and ensure continuous improvement.
4. Assist in external audits conducted by regulatory bodies and customers.
5. Ensure that all employees adhere to Good Manufacturing Practices (GMP) and company policies.
6. Provide training and support to teams on quality systems and regulatory requirements.
7. Stay updated on industry regulations, changes in compliance requirements, and best practices.

Qualifications & Experience:

1. Proven experience as a Quality Systems Engineer / Quality Assurance Engineer in a medical devices manufacturing environment.
2. Strong knowledge of ISO 13485, FDA regulations, and GMP.
3. Experience conducting internal and external audits.
4. Excellent analytical skills with attention to detail.
5. Strong communication and reporting skills.
6. Certification in auditing (e.g., Lead Auditor qualification) is a plus.
7. Ability to work collaboratively and independently in a fast-paced environment.

Fantastic role which covers the UK, mix of home working or based at clients with travel into the office 1-2 per week if not needed with clients.

Please click apply now to be considered.