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This global, market leading Medical Device Manufacturer have, due to their continued growth and success, a superb opportunity for a Quality System Engineer to join their team based in Slough!
This is a permanent position offering flexible working (3 days on site, 2 days from home).
As their new Quality System Engineer, you will be responsible for managing and developing the ISO 13485 QMS, championing Continuous Improvement and Leading the CAPA Process. You will also be responsible for cleading and conducting internal audits and supplier quality.
To be successful as the new Quality System Engineer, you will have proven experience in a Quality Systems focused role within the Medical Devices Sector. You will have strong knowledge and experience of leading the CAPA Process, Supplier Quality, Internal Auditing, Risk Management, PMS and Document Control.
Key responsibilities
- Plan and conduct internal quality audits in accordance with ISO 13485
- Lead and support CAPA activities, including root cause analysis and implementation of corrective actions
- Identify and implement process and QMS improvements
- Manage supplier QA processes, including evaluations and SCARs
- Support change management projects and maintain document control
- Provide analysis and recommendations for quality data trends
- Ensure audit readiness and compliance with applicable standards and regulations
The ideal candidate will have the following skills and experience:
- Educated to degree level in Life Science, Engineering, or a related discipline
- Proven Quality System experience in the medical device industry
- Qualified and experienced ISO 13485 Auditor
- In-depth knowledge of ISO 13485 and medical device regulations
- Proficient in statistical analysis and quality investigational tools
If this feels like the right role for you and you would like to join a company with a defined culture that cares about your development and well-being, please get in touch or apply today!
