Boston Scientific Principal Quality Systems Engineer - Supplier Controls SFMD 

United States, Massachusetts, Marlborough 

776466930

Spencer Gregory Hale

Principal Quality Systems Engineer

About the Role:As the Principal Quality Systems Engineer for material controls, you will be a key player in our Global Quality team. Your mission will be to enhance awareness, visibility, and communication on quality initiatives and objectives. You will support various departmental, functional, site, divisional, and corporate quality goals and priorities. Specifically, you will work with the Internal Operations organization to drive agility and efficiency in supplier onboarding and product launches, collaborating with our partners in different divisions and global regions like APAC.

This role offers the exciting opportunity to engage in supplier controls projects across our global supplier quality management network. Travel will be required to support and collaborate with our suppliers.

Your Responsibilities Include:

• Leading cross-functional project teams across regions, functions, and global stakeholders.
• Utilizing project management best practices to coordinate activities, communicate progress, collaborate on key deliverables, and meet critical timelines.
• Driving continuous improvement and globalization by aligning multiple functional departments with BSC and regulatory requirements.
• Communicating and influencing across the BSC Global Sourcing organization to achieve long-term strategic outcomes.
• Collaborating with Quality system partners such as regulatory, post-market, and design assurance teams.
• Providing continuous and rigorous assessment of Material Controls processes and reviewing documentation to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and Regional Medical Device Requirements.
• Owning highly visible, global, systemic CAPAs while leading through a Community of Practice.
• Guiding functional members and teams in areas 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.
• Participating in or leading BSC Communities of Practice to ensure global processes continuously execute at the highest industry/company level and anticipate emerging regulatory lines of questioning.
• Supporting site, region, and global scale CAPA initiatives, continuous improvement opportunities, and/or projects.

Minimum Qualifications:

• Minimum bachelor’s degree in an engineering or technical discipline.
• 7+ years of related work experience (or 5+ years with a relevant master’s degree) in the regulated industry, including a demonstrated understanding of QSR and ISO standard requirements for material/purchasing controls, product realization, validation, and CAPA.
• The ability to work independently, being organized and self-driven.
• Strong communication skills (both written and verbal) to effectively organize, present, and explain data/information to all internal and external stakeholders.
• Competency in Microsoft software systems (e.g., MS Excel, PowerPoint, Power BI) and QMS software systems (CAPA, SCAR, etc.).
• Willingness to travel domestically and internationally up to 15%.

Preferred Qualifications:

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

Maximum Salary: $ 197000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.