Principal Quality Systems Engineer - Supplier Controls SFMD

Recruiter: Spencer Gregory Hale

 

 

Principal Quality Systems Engineer

 

Location: Marlborough, MA, Arden Hills, MN, or Maple Grove, MN

 

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.

 

What We’re Looking for in You:

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.

 

 

 

 

Requisition ID: 608102 

Minimum Salary: $ 103700 

Maximum Salary: $ 197000 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational