Process Engineer – St. Asaph
A Process Engineer is required for a medical device manufacturer in St Asaph to support both the business and manufacturing partner in process control relating to product safety, manufacturing process risk management, compliance, and product performance.
As a Process Engineer you will:
- Provide support and direction on all quality activities
- Implement lean principles in manufacturing and packaging environments
- Provide expertise in process optimisation techniques e.g., Design of Experiments
- Prepare and execute Validation Master Plans, Process Optimization Studies, Process Validation (IQ, OQ, PQ)
- Ensure robust Process FMEAs / Risk Assessments have been conducted and appropriate controls implemented with proven effects
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
Experience required for a Process Engineer includes:
- A background in process engineering from a medical device manufacturing environment
- Proven experience in new product development and quality engineering related activities in a medical device environment cantered around CAPAS and NCs.
- Knowledge of Medical Device Quality Systems standards and specifically Design Control according to 21CFR820 and ISO 13485, and Risk Management for medical devices in accordance with ISO14971
Be part of an exciting journey for a company who is changing people’s lives. For an informal conversation please call Martin Ash on 01865 546046 or email [email protected]
Keywords: 21CFR820 | ISO 13485 | Risk Management | Medical Devices
Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency