Quality Assurance Engineer
Posted on Feb 19, 2021 by Real Staffing Group
Job title: Design Assurance Quality Engineer
Location: Castletroy, Limerick.
Benefits: Excellent salary, pension, healthcare and yearly bonus.
- Be Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, Supplier quality assurance ) as needed for the project .
- Be responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts within the product life cycle.
- Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements. Review and approve test protocol and reports. Review and approve related execution deviations.
- Ensure process validation activities are completed appropriately and make the link with product design whenever needed.
- Conduct quality functional reviews and DHF compliance reviews.
- Lead risk management activities within the project.
- Actively engage for implementation of the Quality Management System throughout the site, targeting ISO13485/MDSAP certification
- Lead change control activities within the site
- Analyse current and future procedural needs of the QMS
- Organise and manage the plant internal audit system and the corrective action reporting system Conduct Quality Systems audits and assist in training/guidance to other auditors
- Provide training on Quality best practices and QMS processes
- Coordinate the review of Quality procedures associated with plant continuous improvement initiatives
- The successful candidate will have a minimum level 8 degree in related discipline, with a minimum of 3 years of relevant experience and have proven expertise in design assurance including design controls and risk management (ISO 14971), reviewing and approving test protocols, SPC, experience working with Design History Files (ISO 13485, 21CFR820) and have experience working in the medical device sector.
- Additional experience with Class III combination devices in a cleanroom environment, Capital equipment validation and reliability testing would be a distinct advantage.
- Capacity to work with Product Lifecycle Mangement system such as Agile/Documentum or Information system such as TrackWise or Learning Management System such as C2C
- Experience with quality tools and process improvement techniques
- Lean Sigma certified or demonstrated problem solving experience
If you are interested in hearing more about this exciting opportunity and company forward your up to date CV and we can organise a time to discuss further.
Look forward to hearing from you.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales