Job Description
A Senior Design Quality Engineer is required on a PERMANENT basis by CareerWise Recruitment for our Waterford based Healthcare Client. The Senior Design Quality Engineer is a member of the Global R&D Quality Department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. As Senior Design Quality Engineer, you will work primarily on New Product Development projects, collaborating with all functions on all aspects of our integrated innovation process including supporting introduction of new products and processes following stage-gate methodology, risk identification & control and serve as the Voice of the Customer during the full end-to-end product innovation cycle - from concept through feasibility, development & commercialisation. This global position reports to the Senior Manager of Design Quality (Vision Care). THE ROLE: Provide support for development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility. The role includes working with global multidisciplinary teams to ensure medical device development and remediation activities are planned and executed in compliance with design control requirements of the quality management system, ISO, FDA, and other regulatory agencies. Additionally, this role has oversight of the development and maintenance of contact lens device history & risk management files for all assigned products. The role will support marketed product changes and updates (MOB). The role will also support R&D plant activities along with development laboratory from a quality management perspective REQUIREMENTS: Minimum 5+ years in medical device or pharmaceutical industry in Quality, R&D, Engineering or Laboratory environment. Risk management experience. Familiarity with relevant regulations and standards (i.e. ISO-13485, ISO-14971, FDA 21 CFR, EU MDD/MDR) Quality experience in medical device or pharma industry Knowledge of structured problem solving, six sigma, and lean tools Please call Aisling OHagan-Yil today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: QMS Risk Management RA