Senior Quality 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

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 key Quality representative within the Magellan Program - Boston Scientific’s multi-year initiative to harmonize and modernize global business processes, data standards, and enabling technologies. You will ensure Magellan solutions meet Quality System requirements, support testing and deployment activities, and drive quality-focused process improvements. 
 
A critical requirement for this position is the ability to perform and approve Full Track Change Notices (CN) within Windchill. 
 
This role offers the opportunity to positively influence global process transformation while maintaining Boston Scientific’s highest Quality standards. 

Key Responsibilities:

 Quality Engineering Leadership 

• Demonstrate strong commitment to the Quality Policy and compliance with 21 CFR Part 820, ISO 13485, and BSC Quality System requirements. 

• Build quality into all aspects of work and support compliant solution design. 

• Conduct quality impact assessments and execute Full Track CN approvals in Windchill. 

• Apply effective problem-solving methodologies to resolve quality issues. 

Magellan Program Support 

• Analyze, document, and validate quality-related business requirements. 

• Translate complex quality and business needs into functional requirements, user stories, and acceptance criteria. 

• Facilitate workshops to evaluate current-state and future-state workflows.
• Recommend quality process improvements and system enhancements. 

Solution Delivery & Testing 

• Partner with technical, business, and quality teams to ensure quality requirements are understood and implemented. 

• Develop and execute UAT scripts, test plans, and traceability matrices. 

• Validate system readiness and compliance prior to deployment. 

• Ensure change control and documentation governance are upheld. 

Stakeholder Collaboration & Communication 

• Act as liaison between global/regional stakeholders and Magellan teams. 

• Communicate program risks, issues, and decisions clearly to leadership. 

• Provide coaching and SME support to Quality Engineers and Technicians. 

• Support CAPA, Lean, and continuous improvement initiatives. 

Audit & Quality Systems Support 

• Support audit readiness and document non-conformances. 

• Recommend appropriate corrective and preventive actions. 

• Contribute to development of streamlined quality business systems. 

Education & Experience:

• Bachelor’s degree in Engineering, Science, or related field. 

• 5+ years of Quality Engineering or Quality Systems experience in a regulated environment. 

• Ability to perform Full Track CN approvals in Windchill. 

• Strong understanding of ISO 13485 and 21 CFR 820. 

• Experience supporting process or system transformation initiatives. 

• Excellent communication, documentation, and stakeholder management skills. 

Preferred Qualifications 

• Experience with SAP S/4HANA or large-scale ERP modernization. 

• Experience with systems such as SAP, Salesforce, Coupa, or MDG. 

• Knowledge of Agile methodologies and UAT execution. 

• Strong analytical and technical writing skills. 

• Software validation or digital quality systems experience. 

• Systems thinker with strong analytical skills. 

• Comfortable operating in ambiguity with ability to bring clarity. 

• Strong relationship builder and collaborator. 

• High accountability, professionalism, and attention to detail. 

• Able to work effectively across functions and geographies. 

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