Senior Quality Systems Engineer

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

We are seeking a Senior Quality Systems Engineer on a permanent basis to join our team.

Job Purpose:

The Senior Quality Systems Engineer of material controls 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 support the Internal Operations organization and processes to drive Agility/Efficiency in relation to supplier onboarding and product launch with our partners in global regions like APAC.

It will also provide the opportunity to be involved in supplier related projects across the global supplier quality management network in BSC. The role will require an element of travel as part of supporting and working with our suppliers.

Key Responsibilities:

• Leadership of cross functional projects teams across regions, functions, and global stakeholders.

• • Using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical phase timelines
  • Driving continuous improvement and globalization by gaining alignment across multiple functional departments while meeting BSC and regulation requirements
  • Communicating and Influencing across the BSC Global Sourcing organization to deliver long term strategic outcomes

• Provide continuous and rigorous assessment of Material Controls processes and review of documentation throughout the material controls processes to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and Regional Medical Device Requirements.
• Ownership of highly visible, global, systemic CAPAs while leading through a Community of Practice.
• Provide guidance to functional members and teams on in area of process ownership, such as supplier audit/AVL, material qualification, procurement, supplier change and corrective action through audit support and CAPA processes.
• Determining and tracking actionable material controls metrics and trends to ensure proper execution and effectiveness of the global process.
• Participate or lead BSC Communities of Practice to ensure the global processes continuously executes process outputs at the highest industry/company level and anticipates emerging regulatory lines of questioning.
• Support site, region, and global scale CAPA initiatives, continuous improvement opportunities and/or projects

Education & Experience:

• Level 8 Degree in an Engineering or Technical Discipline
• 4+ years of related work experience in the regulated industry including demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA.
• Ability to work independently; organized and self-driven.
• A strong communicator (written and verbal) who can effectively organize, present and explains data/ information with all internal & external stakeholders.
• Competency in Microsoft software systems e.g. MS Excel, PowerPoint, Power BI and in QMS software systems (CAPA, SCAR etc)
• Domestic and international travel up to 15%.

Preferred Qualifications:

• Prior experience within a quality function, preferably supplier quality.
• Knowledge of Medical Device regulations, specifically Material Controls Quality System requirements.
• Lead Assessor ISO13485 certification preferred.
• Familiarity with Drug coated products advantageous.

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.