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Boston Scientific Quality Engineer II 
Ireland, Galway 
527220801

16.08.2024

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Responsibilities

  • Identifies and resolves complex exceptions to work assignments.
  • Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • Participates in Customer Complaints investigation for areas under their control.
  • Continually seeks to drive improvements in product and process quality.
  • Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
  • Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
  • Knowledgeable on Risk Management , BSEN 14971 requirements.
  • Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
  • May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
  • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
  • Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
  • Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.

What we need from you:

  • A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
  • A minimum of 5+ years’ experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
  • Familiar with Internal Audit Processes.
  • We would like you to be a team player and someone who is fully motivated to achieve and demonstrate best practices in line with the department and site objectives.