Senior Quality Systems Engineer

Senior Quality Systems Engineer Of Material Controls

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

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.

Work Mode: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation Assistance: Relocation assistance is not available for this position at this time.

Visa Sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Leadership of cross functional project teams
• Providing continuous and rigorous assessment of Material Controls processes
• Ownership of highly visible, global, systemic CAPAs
• Providing guidance to functional members and teams on in area of process ownership
• Determining and tracking actionable material controls metrics and trends
• Participates or leads in appropriate BSC Communities of Practice
• Supporting both site and global scale CAPA initiatives

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

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.