Sr. Quality Systems Engineer, Document Controls, Global Quality Systems

Additional Locations:  N/A

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

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.

About the role:

Boston Scientific is seeking a Sr. Quality Systems Engineer to join its Global Document & Records Control team and play a key role in shaping how quality processes and digital systems support the business worldwide.

In this role, you will provide global ownership and support for Document Control process elements and associated systems, helping ensure our quality system is effective, compliant, and scalable. You’ll work closely with IT, process stewards, and global partners to maintain system integrity, enhance the Windchill platform, and drive continuous improvement.

This role offers the opportunity to influence the development and evolution of quality system processes and digital tools that enable compliant product development, change management, and document lifecycle management across Boston Scientific.

Your Responsibilities Include:

Global Quality Process & Compliance Ownership for assigned process areas

• Co‑own and support Global Document processes in partnership with designated process stewards, ensuring alignment with corporate procedures and applicable global regulations (e.g., ISO 13485, 21 CFR 820, EU MDR).
• Execute assigned process ownership responsibilities within a global governance framework, collaborating with global process steward(s) who provide compliance oversight, contributing to effective standardization and sustained audit readiness.
• Support the maintenance of a permanent state of compliance through active participation in process monitoring, documentation updates, and issue resolution.
• Assess regulatory, standards, and corporate requirement changes impacting document control, and collaborate with process steward(s) to support timely implementation.
• Act as a delegated subject matter expert for defined aspects of the document control process during audits, inspections, and quality events.

Digital Quality Systems & IT Partnership (Windchill)

• Serve as a Quality Systems business partner and subject matter expert for the Windchill platform, collaborating with IT and cross‑functional stakeholders to support system configuration, enhancements, issue resolution, and lifecycle management.
• Support system governance activities including change control, data integrity, access management, validation support, and user adoption.
• Contribute quality expertise to system upgrades, integrations, and digital workflow improvements, ensuring compliant and efficient product development and quality processes.
• Partner closely with IT/R&D to translate business and regulatory requirements into technical solutions and testing, ensuring alignment with quality and compliance standards.
• Collaborate with IT on root cause analysis, incident management, and timely resolution of system issues, minimizing impact to business operations.

Continuous Improvement & Operational Excellence

• Lead and deliver continuous improvement initiatives across document control and quality system processes using structured methodologies (e.g., VIP), driving efficiency, scalability, and quality culture.
• Identify, analyze, and resolve quality system issues using sound, systematic problem‑solving approaches.
• Ensure quality systems and supporting digital tools are effective, streamlined, and capable of preventing compliance issues.

Quality Events, CAPA & Risk Management

• Act as owner or lead contributor for NCEP and CAPA activities related to global document control and quality system processes.
• Support root cause analysis, corrective and preventive action planning, and effectiveness verification for systemic issues.

Project Leadership & Global Collaboration

• Lead or oversee assigned complex quality system projects of significant scope, including new process implementations, transfers, and acquisition integrations.
• Contribute to the global quality system roadmap, supporting alignment with commitments.
• Participate in and lead activities within Communities of Practice to drive standardization and best practices globally.

Audit & Regulatory Support

• Serve as an audit‑facing subject matter expert for document control and digital quality systems.
• Support external audits and inspections through preparation, execution, back‑room support, and follow‑up activities, including development of training and audit materials.

Leadership, Mentorship & Training

• Mentor and support other Quality Systems Engineers and contribute to capability development within the team.
• Provide training on quality system processes, digital tools, and regulatory requirements as needed.
• Support departmental activities across Quality Systems functions when required.

Required qualifications:

• Minimum of Bachelor’s degree in relevant field.
• Minimum of 5 years of Quality Systems experience.
• Regulated industry experience.
• English Level desired: Advanced.
• Understanding of regulations and standards applicable to the BSC Global Quality System and Document & Records Control processes (ISO 13485, 21 CFR 820, EU MDR, etc.). 

Preferred qualifications:

• Advanced degree.
• Medical device experience.
• Prior Document Control experience.
• Digital product ownership and/or IT project experience.
• Prior experience with PLM/PDM tools, for e.g. PTC (Windchill) tools.
• Strong analytical and communication skills.
• Demonstrated inclusive leadership skills.
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally.
• High sense of urgency and commitment to execution.

Requisition ID: 626073

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 (NYSE: BSX) 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!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

#CRTA #CRGH