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QA Team Leader Manufacturing
ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter
Bradford-on-Avon
On-site
GBP 80,000 - 100,000
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Job summary
An established industry player is looking for a Quality Assurance Team Leader to enhance its growing team in the medical device sector. This pivotal role involves maintaining and supporting the Quality Management System (QMS) while ensuring compliance with ISO13485 and relevant regulations. You will collaborate across departments, advise on quality management processes, and promote continuous improvements. The ideal candidate will have over 5 years of ISO13485 experience and a strong background in the IVD or medical device industry. If you are detail-oriented and passionate about quality assurance, this opportunity is perfect for you.
Qualifications
- 5+ Jahre Erfahrung mit ISO13485 QMS und 2+ Jahre in der IVD- oder Medizintechnik.
- Kenntnisse in ISO13485 und relevanten Vorschriften sind erforderlich.
Responsibilities
- Unterstützung der Implementierung und Wartung von QMS-Prozessen.
- Durchführung von Audits und Schulung der Mitarbeiter zu QMS-Verfahren.
Skills
Qualitätsmanagement
Kommunikationsfähigkeiten
Zusammenarbeit
Detailorientierung
Education
BSc in einem relevanten wissenschaftlichen Bereich
Tools
eQMS System (QT9)
Job description
Quality Assurance Team Leader
We are seeking a Quality Assurance Team Leader to join a medical device company that is growing its team. Your role will be to support and maintain the QMS, ensuring compliance with ISO13485 and other relevant regulations. The role involves working across departments, advising on quality management processes, supporting suppliers and customers, and promoting continuous improvements. Experience in the medical device or IVD industry and software validation is preferred.
Responsibilities
• Support implementation and maintenance of QMS processes
• Administer eQMS system (QT9)
• Conduct audits and ensure compliance
• Train employees on QMS procedures
• Monitor performance and suggest improvements
• Provide backup for QA team admin tasks
Qualifications
BSc in a relevant scientific discipline or equivalent experience
5+ years of ISO13485 QMS experience
2+ years in IVD or medical device industry
Knowledge of ISO13485, 21 CFR Part 820, and relevant regulations
Strong communication and collaboration skills
Experience with QMS systems and document control
The role requires a self-motivated individual with a strong attention to detail and ability to work across teams.
To be considered for this opportunity you will need to have the right to work in the UK.
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