Senior R&D Quality Engineer in Eastleigh, Hampshire

Advanced Resource Managers are currently supporting a Manufacturing Company who are the global leader in contact lenses. They are searching for a Senior R&D Quality Engineer to join their team in Chandlers Ford, Eastleigh on a permanent basis. This position offers a hybrid working model 3 days onsite and 2 days working from home.

The Senior R&D Quality Engineer plays a key part in concept research control and design activities for new product introductions.

Responsibilities:

• Ensure compliance to global Design Control and Risk Management procedures, which adhere to ISO 13485, ISO 14971, MDSAP and MDD/ MDR.
• Developing and reviewing documentation for clinical trials, product/process development, and validation.
• Supporting the development of inspection methodologies and acceptance criteria.
• Assisting in maintaining Quality System Regulation requirements and participating in audits.
• Fostering a culture of quality awareness and teamwork.
• Collaborating with Regulatory Affairs and R&D to ensure compliance with applicable standards.
• Participating in Regulatory Agency Inspections and supporting Manufacturing in Validation and Control Planning.

Requirements:

• Extensive experience in the medical device field, preferably in Vitro Diagnostics or Pharma.
• Bachelor's degree in engineering or a related science discipline.
• Technical proficiency in quality systems, including ISO standards and FDA regulations. This includes practical application of ISO 13485, ISO 14971, and FDA Quality System Regulation CFR 21 Part 820. MDSAP & MDD/ MDR is ideal.
• Experience with Good Manufacturing Practice (GMP) and ideally with Good Laboratory Practice (GLP) or Good Clinical Practice (GCP).
• Knowledge of Qualitative and Quantitative data analysis and statistical tools.
• Six Sigma Green Belt or Certified Quality Engineer (CQE) qualification preferred.
• Project Management certification is a plus.

Benefits:
In addition to competitive compensation, they offer a comprehensive benefits package, including 25 days of holiday, a pension scheme, Private Medical coverage, life assurance, access to their Wellness Platform, discounted contact lenses, and more.

Apply via Linked In, or alternatively, you can contact me on +44 23 9222 8211 or email me at

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.