Senior Quality Systems Engineer – Material Controls

Boston Scientific; Marlborough (MA); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Systems Engineer of Material Controls to support global supplier quality initiatives and ensure compliance with FDA, ISO 13485 and BSC quality requirements. The role is based in Marlborough, MA and requires 25% travel.

You will lead cross-functional teams, drive CAPAs, and oversee supplier audits, qualifications, and material change management while pursuing continuous improvement across the global supply chain.

Qualifications

• Bachelor's degree with 5 years of related experience or Master’s with 3 years.
• Medical device manufacturing, quality or regulatory/compliance environment.
• Experience in Supplier Quality, Supplier Engineering, or Sourcing.
• Understanding of 21 CFR Part 820 and ISO 13485.
• Willing to travel 25% of the time.
• Technical writing and documentation skills.

Responsibilities

• Lead cross-functional project teams and coordinate activities to meet timelines.
• Assess Material Controls processes for compliance with FDA, ISO 13485, and global BSC processes.
• Own global CAPAs and guide supplier audits, qualifications, and changes.
• Track material controls metrics and trends for effective process execution.
• Support CAPA initiatives and continuous improvement projects.

Skills

Technical writing

Regulatory knowledge

Supplier quality

Project management

Travel readiness

Education

Bachelor's degree

Master's degree

Job description

Boston Scientific is seeking a Senior Quality Systems Engineer of Material Controls to support global supplier quality initiatives and ensure compliance with FDA, ISO 13485 and BSC quality requirements. The role is based in Marlborough, MA and requires 25% travel.

You will lead cross-functional teams, drive CAPAs, and oversee supplier audits, qualifications, and material change management while pursuing continuous improvement across the global supply chain.