Senior Quality Systems Engineer
Boston Scientific
Summary
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 Material (Supplier) controls processes, ensuring compliance to Medical Device regulations and BSC Quality System requirements.
Job description
Your Responsibilities Will Include
- Leadership of cross functional projects teams
- 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
- Providing 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 Medical Device Requirements
- Ownership of highly visible, global, systemic CAPAs while leading through a Community of Practice
- Providing 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
- Participates or leads in appropriate 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.
- Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects
Required Qualifications
- Minimum of a Bachelor's degree with 5 years of related experience or minimum of a Masters degree with 3 years of related experience
- Medical device manufacturing, quality or regulatory/compliance environment
- Previous experience in a Supplier Quality, Supplier Engineering, or Sourcing organization
- Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
- Must be willing to travel 25% of the time
- Technical writing and documentation skills
Preferred Qualifications
- Degree(s) in Science or Engineering
- 5+ years of experience in Supplier Quality, Supplier Management, or Quality Systems
- Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
- Project management skills
Requirements
- Minimum of a Bachelor's degree with 5 years of related experience or minimum of a Masters degree with 3 years of related experience
- Medical device manufacturing, quality or regulatory/compliance environment
- Previous experience in a Supplier Quality, Supplier Engineering, or Sourcing organization
- Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
- Must be willing to travel 25% of the time
- Technical writing and documentation skills
- Degree(s) in Science or Engineering
- 5+ years of experience in Supplier Quality, Supplier Management, or Quality Systems
- Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
- Project management skills
Benefits
- Health insurance
- 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.