Description
I am currently recruiting for Quality Engineers with my client, a leading medical device company specialising in contract manufacture of devices and components, based in Galway. This is a great opportunity to join an excellent company throughout their expansion with competitive salaries on offer.The quality engineer will perform an active role in quality planning and new product introduction, from a quality perspective. This will involve:
- Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria.
- Works closely with product development engineering and the client team to establish the system design specifications and product requirements.
- Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles.
- Performs and documents all engineering studies and reports to satisfy the master verification plan.
- Plans, coordinates and executes design verification testing to directly support the master verification plan.
- Participates with the engineering team to establish and review the design FMEA.
- Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment.
- Possesses a comprehensive understanding of ISO10555 principles, design FMEA practices, and any industry standards to ensure products satisfy all ISO 13485 requirements.
- Support various QA/RA activities including quality management, system reviews, audits, etc.
- Support risk management activities
- Evaluation of new products, assuring the safety and efficacy of the devices
- Design verification and shelf life protocols / reports review.
- Root cause investigations; drive problem solving efforts for quality issues
- Clear present information to Regulatory Affairs to minimize Regulatory Agency questions
Key Requirements:
- 5+yrs industry experience in a medical device-manufacturing environment.
- Working knowledge of FDA and ISO Quality systems for Medical device companies.
- New product Introduction and manufacturing process transfer experience would be a distinct advantage
- Process validation experience including new process start-up, typically drafting MVP's, validation protocols and coordinating validation execution and FMEA activities
- Technical expertise in the review of technical files and design dossiers to ensure compliance to current standards
- Degree in Science or Engineering.
If you feel you would be a good fit for this role or know someone he is please apply directly to this advert or contact Derek Sheridan for further information.