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Quality Engineer I & II - Complaints Job

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Date: Jun 9, 2021

Location: Galway, G, IE

Company: Boston Scientific

 

Our Mission:

At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care.

 

 

Responsibilities: 

  • Demonstrates commitment to the Quality Policy (patient safety and product quality) through their 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.
  • Ownership for the execution of investigations applicable to product complaints and completion of investigation records within the Global Complaints System Management system.
  • Completes or ensures execution of applicable analysis on returned product samples using available methods/equipment and applying problem solving and investigation skills.
  • Seeks and drive continuous improvement initiatives to investigation methodology and associated processes and lead applicable projects of improvement.
  • Make decisions and determine escalation pathways, as well as demonstrating ability to work on one’s own initiative and with minimum supervision is required.
  • Preparation and provision of complaint trend data to internal customers and sharing of complaint data and trend analysis at applicable review forums.
  • Development and maintenance of collaboratively relationships within the Galway CIS team and with other CIS centres and Complaint Management centres (CMCs) across the Post Market Quality Assurance function.
  • Development and maintenance of partnerships with Quality Operations, Design Assurance and R&D for the execution of insightful investigations and to support product performance improvements.

 

 

What we need from you: 

  • HETAC Level 8 qualification in a STEM subject with a min. of 2-3 years relevant work experience.
  • Demonstration of problem solving, process improvement and/or project management skillsets and application.
  • Demonstration of taking initiative to drive improvement and change.
  • Knowledge on product design, manufacture, functionality and/or clinical use environment. Experience of Structural Heart product design or manufacturing would be an advantage.
  • Experience of Angiographic image review experience would be an advantage.
  • Good technical capabilities, communication skills and organisation skills. Ability to analyse data to gain insights and to share information effectively.
  • Proven ability to work well with teams but also with minimum supervision.
  • Hepatitis B Vaccinations course required to work with returned decontaminated product.


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