Job Description
Product Quality Professional - North Dublin. Core tasks and responsibilities: Contributing and leading in a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling and validation. Active in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, continuous improvement changes, and post-production (proactive surveillance). This will require a systems mindset incorporating a cross-technology understanding, in addition to a core appreciation of risk and regulatory requirements. Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control. Focus on and be responsible for process quality design improvements and updating quality system procedures to achieve both fully compliant and lean processes. Interested applicants should have: At least 5 years relevant experience in a regulated environment, with a core appreciation of FDA regulations and Risk Management, including writing and/or reviewing Quality related procedures, plans, and reports. Minimum of a third level qualification (Diploma/Degree) in an appropriate discipline (Quality Management, Mechatronics, Electronics or Mechanical Engineering) OR appropriate and commensurate experience. Experience in being a part of teams and projects with strong communications - written and verbal. Ability to work in technically complex multi-discipline areas across the whole supply chain, including the supplier environment. We seek a high-paced individual who is eager and passionate in developing and delivering quality solutions in close collaboration with key stakeholders. Strong skills and ability to influence cross-functional teams to drive workscope to completion. Good organization skills. Cross-technology and cross-discipline collaboration skills. An aptitude for systems level thinking, including development of standard operating procedures. Ability to write structured, concise, unambiguous technical English with high attention to detail. Core understanding of statistical analysis and design of experiments experience. Familiar with statistical software packages e.g. Minitab. Computer literacy (including MS Word/ Excel/ PowerPoint/ MS Project). Skills: quality medical device science