Senior Quality Engineer, P4

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

Boston Scientific is seeking a highly motivated Senior Quality Engineer on a permanent basis to join our team.

Job Purpose:

The Senior Quality Engineer will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Specifically, this role will lead or support Quality initiatives, ensuring compliance to Medical Device regulations and BSC Quality System requirements relating to Magellan with a continuous improvement mindset.

Key Responsibilities:

• Responsible for the communication and documentation of internal and external compliance-related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities.
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
• Documents audit non-conformances, evaluates impact, and makes recommendations for corrective actions.
• Communicates non-conformances to owners, managers, directors, and upper management.
• Supports departmental, functional, divisional, and corporate quality goals and priorities.
• Act as leader or team member in supporting quality disciplines, decisions, and practices.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Participates on CAPA and Lean Business project teams as appropriate.
• Other duties as necessary or required by the department or organisation.

Education & Experience:

• Honours Bachelor's degree in Science or Engineering.
• Minimum 5+ years experience in a medical device manufacturing, quality or regulatory/compliance environment
• Previous experience in Quality Systems or Country/Distribution QA or having experience in working in the Commercial/Supply Chain organization.
• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Technical writing and documentation skills
• Project management skills

 
Preferred Qualifications

• Degree(s) in Science or Engineering
• 5+ years of experience in Quality Systems
• Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
• Good working knowledge of SAP would be beneficial
• Advanced level of Microsoft Excel (including macros) and databases development
• Software validation experience

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 isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.  Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com