Senior Quality Assurance Engineer - Parkmore Galway
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.
Key Responsibilities
Identify and resolve complex exceptions to work assignments.
Summarize, analyze, draw conclusions and make appropriate decisions from test results or other process-related findings.
Take responsibility and independent authority to make decisions related to product quality, including disposition of non-conforming product.
Participate in customer complaints investigation for areas under their control.
Continuously seek to drive improvements in product and process quality.
Be knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decisions daily.
Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
Evaluate in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect.
Be knowledgeable on risk management, BSEN 14971 requirements.
Compile and analyze operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
May participate directly in new product/technology transfer to ensure compliance with all internal and regulatory requirements.
Use knowledge of Six Sigma, statistical analysis and lean principles to investigate and solve problems and improve quality.
Provide technical guidance to associate quality engineer, technician and inspection staff.
Be a good team member, fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
Deal with suppliers, other engineering disciplines within and outside of the site and customers when needed.
Be familiar with the internal auditing process.
Education & Experience
A Level 8 degree (240 credits) or equivalent in an engineering or science related discipline.
A minimum of 3‑4 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.
Experience in extrusions & mouldings is desirable.
Seniority level
Associate
Employment type
Full‑time
Job function
Quality Assurance and Engineering
Medical Equipment Manufacturing
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