CK Group are currently recruiting for a QA Manager to join a specialist Medical Device organisation at their site in Saffron Walden on a full time, permanent basis. This role offers a salary of £45,000 - £50,000 DOE
The main purpose of the role will be to:
- Ensure current manufacturing processes comply with internal and external specifications and standards.
- Manage validation of equipment and production processes.
- Develop and maintain KPI
- Manage production process scale-up activities.
- Maintain ISO 13485 compliant QMS, Quality Management System.
o Manage Change Control process.
o Manage and lead CAPA process to resolve production-related issues.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree in Mechanical or Chemical Engineering (2:1 or above).
- 5+ years QA Engineering experience in either Medical Devices or Pharmaceuticals.
- IQ/OQ of equipment and PQ of processes.
- QMS experience e.g. ISO 13485, 21 CFR Part 820.
- Commutable daily to Saffron Walden, Essex.
- Experience working with drug/device combination products.
- ISO 7 clean room experience (or higher specification).
- Understanding (or previous experience of) process FMEA and design control.
Entitlement to work in the UK is essential. For more information or to apply for this position, please contact Natalie Wood on 01246 457723 or email email@example.com. Please quote reference 50241 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Natalie Wood
- Phone: 01246 457700
- Reference: 50241
Website: CK Group
- Posted: 30th March 2021
- Expires: 27th April 2021