Quality Engineer - County Wexford. Core Purpose: A Medical Device client is recruiting for an experienced Quality Engineer with New Product Development experience? Core Responsibilities: Ensure that new product designs and the processes for manufacturing them meet all local, corporate and divisional requirements with respect to safety and efficacy. Represent quality interests and concerns on project teams. Lead risk management activities. Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance. Lead the Quality engineering activities for NPD projects. Develop design and process risk management documentation with cross-functional support. Review design control compliance requirements for NPD projects. Review and approve all design file outputs from the NPD projects. Support the development of device Design Inputs, Design Outputs, Product Specifications, and applicable design control documents. Lead the development of the DFMEA, co-ordinating input from the other Design Sub-team members. Support (or lead) development of the PFMEA. 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 optimisation or determine causes of process variation. Initiate corrective actions as required. Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports. Support assessment of Biocompatibility testing required as per ISO10993 and company procedures. Assist in generation of test protocols and Stability Studies in support of expiration dating. Identify quality systems engineering improvement opportunities and execute through the change management system. Participate in internal audit and supplier audit programmes. Development of robust action plans, projects and verification activities for elimination of potential compliance and CAPA related risks, as required. Alignment of the quality system with changes in global and corporate quality management standards, policies and regulations. Validation planning and execution. Qualifications & Experience: Should have a minimum of 5 years' experience in the medical device or pharmaceutical industry. Requires a knowledge of quality management systems ISO 13485, GMP etc. Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines. Excellent organisational skills and problem solving techniques.
230 days ago