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 withthe mission is 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:

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

Qualifications & Experience:

• Proven experience as a Quality Systems Engineer / Quality Assurance Engineer��in a medical devices manufacturing environment.
• Strong knowledge of ISO 13485, FDA regulations, and GMP.
• Experience conducting internal and external audits.
• Excellent analytical skills with attention to detail.
• Strong communication and reporting skills.
• Certification in auditing (e.g., Lead Auditor qualification) is a plus.
• 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 considere