Quality Engineer - Wexford

R.T.Lane Recruiting Talent

Waterford, Wexford

Quality Engineer - Permanent - Wexford x 3. R.T.Lane Recruitment have got 3 vacancies in Wexford for Quality Engineers within Medical Devices. These roles offer progressive opportunities due to ongoing expansion of the manufacturing site. Great opportunity to join a company interested in developing and progressing talent. Leads the Quality engineering activities for NPD projects, supporting and participating in NPD teams. Develops design and process risk management documentation with cross-functional support. Reviews design control compliance requirements for NPD projects. Reviews and approves all design file output from the NPD projects. Support the development of device Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents. Lead the development of the DFMEA, coordinating input from the other Design Sub-team members. Support (or lead) development of the PFMEA. Executes product sterilisation validation/re-validation and sterile adoption requirements. Develop or assist in development of inspection and test methods per product specifications. Perform test method validations and component qualifications as required. Perform DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required. Supports assessment of Biocompatibility testing required as per ISO10993 and company procedures. Develop or assist in development of inspection and test methods per product specifications. Develop or assist in generation of test protocols and Stability Studies in support of expiration dating. Identifies quality systems engineering improvement opportunities and executes through the change management system. Participates in internal audit and supplier audit programmes. Participates on teams responsible for investigating and providing corrective action for production and supplier nonconformances. Development of robust action plans, projects and verification activities for elimination of potential at compliance and CAPA related risks, as required. Please call Rachel Lane Today with your cv on 022 46969 or get in touch rachel@rtlanerecruitment.ie. This job originally appeared on RecruitIreland.com.

2487 days ago