2 months ago
My client, a pioneering medical devices company, is currently looking for a Process Engineer to join on a permanent basis. The Process Engineer will play a key role as part of the consumables project team, working both with the manufacturing partners and the business to ensure that the development and maintenance of processes to the consumables manufacturing environment supports an effective quality system.
Key Job Responsibilities for this position include:
*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
*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.
Qualifications / Requirements:
*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.
*Degree in engineering or technical discipline
*Manage assigned CAPA and NCs.
*Proven experience in new product development and quality engineering related activities in a medical device environment
*Flexibility to operate within various client organisation Quality Management Systems
The ideal candidate must be highly proactive, and results focused with the ability to influence others within the team. They need to have a proven ability to achieve business' targets and possess strong technical problem-solving skill. A self-motivated individual who can work both individually and as part of a team.
Process Engineer, North Wales / Cheshire