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At Boston Scientific, we offer the chance to unleash your potential by working with diverse, high‑performing teams to tackle critical health industry challenges. With access to the latest tools, information and training, we support your skill and career advancement and ensure you progress toward whatever ambitions you pursue.
Advancing possibilities for a brighter tomorrow
Boston Scientific is seeking a highly motivated Quality Engineer II on a permanent basis to join our team.
Job Purpose
Demonstrates commitment to the Quality Policy (patient safety and product quality) through daily execution of sound quality practices and maintenance of an effective quality system. Understands and complies with all regulations governing the quality systems. Ensures direct reports are aware of their commitment to patient safety and product quality, keep current with training requirements, and comply with all other regulations governing their work.
Key Responsibilities
Identifies and resolves complex exceptions to work assignments.
Summarizes, analyzes, draws conclusions and makes appropriate decisions from test results or other process related findings.
Has responsibility and independent authority to make decisions related to product quality, including disposition of non‑conforming product.
Participates in Customer Complaints investigation for areas under control.
Continually seeks to drive improvements in product and process quality.
Knowledgeable on QSR and ISO/MDD standards, promotes best industry practices, and makes daily decisions utilizing the quality engineering manager/site QA Director as final arbitrator on critical quality decisions.
Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
Evaluates new equipment/processes/chemicals for environmental impact/effects to eliminate or lessen them.
Knowledgeable on Risk Management, BSEN 14971 requirements.
Compiles and analyzes 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 to all internal and regulatory requirements.
Uses Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
Provides 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 the Site and customers when needed.
Is 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 at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
Familiar with Internal Audit Processes.
Team player and someone fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
Experience in Extrusions & Mouldings is desirable.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific is not just business, it’s personal. If you are a natural problem‑solver with imagination, determination and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Boston Scientific is a proud equal opportunity and affirmative action employer. We are committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please contact us via email.
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