Senior Quality Engineer, Cambridgeshire, Medical Devices, £Competitive Salary

Job Reference: #17283 Add to saved jobs

  • Location Cambridge, Cambridgeshire, Northampton, Luton, Bedford, Peteborough
  • Permanent
  • Sector Medical Devices

Job Summary

Are you a well-rounded QA/RA professional with design history file experience? This company offer an exciting and challenging working environment where development timescales are short and the specifications demanding but rewarding. Today is a great time to join their rapidly expanding team. They can offer the opportunity to work on world class projects, learn new skills and create breakthrough products for leading global brands. Senior Quality Engineer, £Competitive Salary, Cambridge, Medical Devices Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Job Overview

• Working within our multidisciplinary teams on major product development projects
• Development, evaluation and auditing of Design History Files (DHF) internally
• As well as for our suppliers and clients for a range of products and processes in primarily the medical sector
• To document gaps affecting design control elements such as inputs, outputs, design verification and validation, DMR, etc
• Remediate the previous as necessary in a tactful, professional and effective manner

Skills Required

• 10+ years-experience in Medical Device/Pharma roles within Quality roles
• 2.2 or above in Engineering or other Physical Sciences is essential
• Experience of submissions to RA including successful submission in either the US or EU.
• Quality Management experience in the medical device and/or pharmaceutical manufacturing/development area – ISO 13485, FDA 21 CFR Parts 820, 211 and 210
• Good knowledge of Design History File Documents
• Able and willing to travel fortnightly in the UK and/or overseas

Contact Details

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Meet are good people who are great at recruitment. We’re proud to partner with the industry’s leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at: www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/

Apply Today

* Indicates a required field