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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 Engineerto join the team.
Job Overview:
The Quality Systems Engineer / Quality Assurance Engineerwill 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.
- Proven experience as a Quality Systems Engineer / Quality Assurance Engineerin 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 considered.
