Quality Engineer (Med Devices)
- Experience Level
- Experienced (non-manager)
QUALITY ENGINEER, MED DEVICE, BIRMINGHAM, PERMANENT
Headquartered in Birmingham, for over 25 years, this Medical Device company has been at the forefront of research and development in the sector, playing a critical role in delivering innovative medical solutions for the diagnosis and management of blood cancers and immune system disorders. They have asked me to identify their next Quality Engineer to join their ambitious, ever-growing QA team as they look to take their manufacturing processes to the next level. In a market where single digit growth appears to be the norm, our Client is growing in double-digits - a fantastic time to join this Company!
Enough about the Client though. What about you? What will you be doing?
Reporting into the Quality Engineering Manager and acting as an integral member of the QA team, your primary role will be to ensure the company and its manufacturing processes maintain compliance to all relevant regulatory standards and regulations, both internally and externally (ISO 9001/ 13485, FDA CFR 820 part 21, QSR's) to produce consistent quality products. The goal of this position is to identify and advise on quality related issues, resulting in improved metrics such as Overall Equipment Effectiveness (OEE) and increased quality for delivery performance.
On a daily basis, whilst you will be working as part of a small, ambitious team with a strong team bond, you will have a good amount of autonomy, meaning that if you enjoy developing existing processes whilst taking lead on site based QMS activities, this is the ideal role for you.
To thrive in this role, you must have:
- Degree or equivalent in Biological Sciences (or similar)
- Working knowledge of FDA part 820, ISO 13485, ISO 14791, PFMEA
- Experience of NCR/ CAPA in an IVD/ medical device/ regulatory industry
- Strong understanding of Quality principles/ systems
If playing a pivotal role in providing diagnostic products, instrumentation and materials to clinical and laboratory professionals globally on behalf of a company with a proud culture of fostering the very best talent in the market excites you, please do not hesitate to contact Recruitment Consultant James Fitzjohn on +44 (0)20 3907 1988, or email him at firstname.lastname@example.org. If this role is not suitable, James is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
i‐Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i‐Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Biometrics.
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