Job Description
Product Quality Professional - North Dublin
Ref No: DT18336
Competitive salary
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).
* Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control.
Required Qualifications and Skills:
* At least 5 years' relevant experience in a regulated environment, with a core appreciation of FDA regulations and Risk Management.
* 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.
About Us:
We are seeking 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).