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 workplaceits 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.
Click 'Apply Now' Please note, you must have a valid working permit and visa for Ireland.
Skills: CAPA non conformances projects SOPs Benefits: Flexitime Paid Holidays Gym VHI Pension Bonus Life Assurance