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Quality Engineer I

Maintain and improve quality systems to ensure regulatory compliance and patient safety
Galway, Galway, Ireland
Junior
yesterday
Boston Scientific

Boston Scientific

A global medical device manufacturer specializing in products for various interventional medical specialties, including cardiac, vascular, and urological conditions.

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Quality Engineer I

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

Boston Scientific is seeking a highly motivated Quality Engineer on a defined-term basis to join our team.

Job Purpose:

You will demonstrate commitment to the Quality Policy (patient safety and product quality) through your daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.

Key Responsibilities:

  • Takes a preventive approach to Quality Assurance, proactively identifying potential issues.
  • Uses strong organizational skills and effective time management to ensure work is completed in a timely manner.
  • Effectively prioritizes workload to ensure timely completion of critical tasks.
  • Plans and executes daily tasks to ensure timelines are met.
  • Takes a pragmatic and logical approach to challenges faced.
  • Explains technical topics clearly to diverse stakeholders through effective communication.
  • Promotes a culture of continuous improvement through reflection and factoring in previous learnings.
  • Makes informed decisions related to product quality, including dispositioning non-conforming product.
  • Evaluates complex quality issues and selects the most appropriate problem-solving tools/techniques.
  • Completes timely scoping and containment of product-related issues when required.
  • Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment, and Investigation.
  • Identifies and drives Corrective Actions when required, to prevent/eliminate/facilitate/mitigate the re-occurrence of non-conformances.
  • Familiar with BSC Quality Systems and ISO/MDD/MDR standards.
  • Involved in internal and external audits, including audit facing and presenting processes/documents to auditors as a subject matter expert.
  • Knowledgeable on Risk Management, Design Outputs, and product/process Risk Documentation.
  • Involved in change control for work instructions, protocols/reports, and technical documents, either as a change owner or quality approver.
  • Maintains relationships and gives technical guidance to Quality Technicians.
  • Deals with suppliers, other engineering disciplines within and outside of the site as required.

Education & Experience:

  • A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
  • A minimum of 3+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.

So, choosing a career with Boston Scientific isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

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Quality Engineer I
Galway, Galway, Ireland
Engineering
About Boston Scientific
A global medical device manufacturer specializing in products for various interventional medical specialties, including cardiac, vascular, and urological conditions.