Job Description

Process Engineer
Full time, permanent
St Asaph
Monday to Friday 08:30 - 16:30
Competitive Salary
Excellent company benefits

As a Process Engineer you will be working with a privately owned medical device company that has excellent development and growth plans across 2021. As a company they are proud of what they do and make a real difference to lives daily.

The position will play a key part supporting both the company and manufacturing partner to ensure the development and maintenance of processes and documentation is being managed correctly for the Quality Management System.

Main duties will include:

Ensure robust Process FMEAs / Risk Assessments Provide support and direction on all quality activities necessary for the project team to achieve process control deliverables
Provide expert guidance in process optimisation techniques
Prepare and execute Validation Master Plans, Process Optimization Studies, Process Validation (IQ, OQ, PQ)
Ensure Quality Inspection Procedures, Control Plans and batch release processes and documentation are in place with proven effects and full traceability
Monitor, measure and analyse data including product and process capability, to identify process and Quality Management System deficiencies and continuous improvement opportunities
Utilise Six Sigma methodologies (DMAIC - Define, Measure, Analyse, Improve and Control) and carry out statistical data analysis to effectively scope and manage improvement activities
Implementation of lean principles in manufacturing and packaging environments
Plan, design and specify improvements to existing processes to improve productivity, quality, safety and efficiency.
Prepare manufacturing and validation document amendments in relation to design or process change
Document, justify, review or analyse whether a proposed change to a design or process will not enhance the risk level

For the position you will have:
A background in process engineering in 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.
A relevant Engineering or technical Degree
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
Proven experience in new product development and quality engineering related activities in a medical device environment
Knowledge and use of a variety of risk management tools, design and process control activities, verification and validation testing methodologies to support product quality for new and existing product development
Flexible to work across multiple geographical locations in the UK including supplier sites as and when required

If your interested in this Process Engineer position and have the relevant skills set to match the criteria please submit your CV and the relevant consultant will be in touch to discuss the next stages in your application.