Quality Systems Engineer III
Boston Scientific
Summary
The Quality Systems Engineer III supports the Global Quality Systems and Acquisition Integration team within the Document and Records Control function. This role provides global process and digital system support, partnering with IT and cross-functional stakeholders to maintain compliance, support continuous improvement and ensure effective quality system performance. The position contributes to the development, maintenance and enhancement of quality system processes and tools that support compliant information lifecycle management across Boston Scientific.
Job description
About the role
The Quality Systems Engineer III supports the Global Quality Systems and Acquisition Integration team within the Document and Records Control function. This role provides global process and digital system support, partnering with IT and cross-functional stakeholders to maintain compliance, support continuous improvement and ensure effective quality system performance. The position contributes to the development, maintenance and enhancement of quality system processes and tools that support compliant information lifecycle management across Boston Scientific.
Your responsibilities will include
- Execute assigned process ownership responsibilities within a global governance framework while collaborating with global process stewards who provide compliance oversight.
- Support standardization efforts and maintain audit readiness in accordance with applicable regulations and standards, including ISO 13485, 21 CFR Part 820 and EU MDR.
- Participate in process monitoring, documentation updates, regulatory implementation activities and issue resolution to maintain a permanent state of compliance.
- Serve as a quality systems subject matter expert and business partner for digital platforms supporting document and records control processes.
- Collaborate with IT and cross-functional stakeholders to support system configuration, enhancements, issue resolution and lifecycle management activities.
- Partner with IT to translate business and regulatory requirements into technical solutions, validation activities and testing strategies.
- Support root cause investigations, incident management and timely resolution of system-related issues to minimize business disruption.
- Support continuous improvement initiatives using structured methodologies, including VIP, to drive efficiency, scalability and operational excellence.
- Identify, analyze and resolve quality system issues using systematic problem-solving methodologies, considering common practice or procedures.
- Drive process enhancements that strengthen quality culture and improve overall system effectiveness.
- Serve as an owner or contributor for nonconformance, exception and CAPA activities.
- Support root cause analysis, corrective and preventive action planning, implementation and effectiveness verification.
- Contribute to risk management activities and systemic issue resolution efforts.
- Support global quality system projects, including process implementations, business transfers and acquisition integrations.
- Contribute to the global quality systems roadmap and support alignment with organizational commitments and priorities.
- Participate actively in Communities of Practice activities to promote standardization and adoption of best practices.
- Support external audits and regulatory inspections through preparation, execution, back-room support and follow-up activities.
- Develop training materials, audit support documentation and related compliance resources.
- Guide and support Quality Systems Engineers while contributing to team capability development.
- Deliver training on quality system processes, digital tools and applicable regulatory requirements.
- Support broader departmental and Quality Systems initiatives as business needs require.
What we're looking for in you
Minimum requirements:
- Bachelor's degree
- Minimum 3 years' experience in quality systems within a regulated industry
- Working knowledge of regulations and standards applicable to the Boston Scientific Global Quality System and Document and Records Control processes, including ISO 13485, 21 CFR Part 820 and EU MDR.
- Demonstrated experience partnering with cross-functional stakeholders to support quality system processes and digital tools
- Previous experience or open to learning digital product ownership, quality systems application support and/or IT project experience
Preferred qualifications:
- Medical device industry experience preferred
- Prior document control and records management experience preferred
- Experience supporting audits, inspections and CAPA activities
- Experience implementing or working with Windchill or another PLM system
Requirements
- Bachelor's degree
- Minimum 3 years' experience in quality systems within a regulated industry
- Working knowledge of ISO 13485, 21 CFR Part 820 and EU MDR
- Demonstrated experience partnering with cross-functional stakeholders to support quality system processes and digital tools
- Previous experience or open to learning digital product ownership, quality systems application support and/or IT project experience
- Medical device industry experience preferred
- Prior document control and records management experience preferred
- Experience supporting audits, inspections and CAPA activities
- Experience implementing or working with Windchill or another PLM system
Benefits
- Annual bonus target
- Long-term incentives
Company overview
Boston Scientific Corporation is a global leader in the development, manufacturing, and marketing of minimally invasive medical devices used in interventional medical specialties. Founded in 1979 and headquartered in Marlborough, Massachusetts, the company focuses on transforming patient lives through innovative medical solutions across a wide range of therapeutic areas including cardiology, endoscopy, urology, pulmonology, and neuromodulation. With approximately 53,000 employees worldwide and operations in 40 countries, Boston Scientific serves over 44 million patients annually. The company invests heavily in research and development, allocating $1.6 billion to R&D in 2024, and maintains a strong commitment to quality, patient safety, and meaningful innovation. Boston Scientific's product portfolio includes advanced technologies such as cardiac rhythm management devices, coronary stents, ablation systems, endoscopy equipment, and neuromodulation therapies, all designed to improve patient outcomes and quality of life through less invasive treatment options.