Quality Engineer II
About Your New Employer:
Boston Scientific in Galway is at the heart of cutting-edge innovation, transforming lives globally through its life-changing medical devices. As a key player in the MedTech hub of Ireland, the Galway site is renowned for its pioneering work in minimally invasive therapies, boasting a dynamic team that thrives on collaboration, creativity, and making a real difference.
Joining Boston Scientific means being part of a mission-driven culture where your work directly impacts millions of patients worldwide. With state-of-the-art facilities, opportunities for growth, and a commitment to empowering employees, Boston Scientific Galway is more than a workplace—it’s where passion meets purpose, driving innovation to improve lives every day.
We have permanent and contracting vacancies available in Galway in Line Support function and Projects.
What they offer you:
- A Career with a Meaningful Purpose
- A Collaborative Culture
- A defined Career Development plan
- The Opportunity to Develop and Innovate
- Competitive Benefits
- An excellent Work-Life Balance
- Dedicated Corporate Social Responsibility
Your New Job as a Quality Engineer II:
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 Skills You Need:
- A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
- A minimum of 3- 5 years’ experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
- Familiar with Internal Audit Processes.
- Team player and someone who is fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
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Please note, you must have a valid working permit and visa for Ireland.