Global Supplier Quality & Quality Systems Lead

Boston Scientific; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Systems Engineer for material controls to bolster quality initiatives across global sites. You will lead cross-functional projects, drive CAPAs, and ensure compliance with FDA 21 CFR Part 820 and ISO 13485, while aligning with global sourcing.

The role requires 25% travel and a strong background in supplier quality and regulatory environments. The position is hybrid, based in Arden Hills, MN, with opportunities to influence process ownership, audits,

Qualifications

• Bachelor's degree with 5+ years of related experience or Master's with 3+ years.
• Experience in medical device manufacturing, quality, or regulatory/compliance.
• Knowledge of 21 CFR Part 820 and ISO 13485.
• Willingness to travel 25%.

Responsibilities

• Lead cross-functional project teams and coordinate activities.
• Drive continuous improvement and global alignment.
• Influence across Global Sourcing to achieve outcomes.
• Assess Material Controls processes for FDA/ISO compliance.
• Own CAPAs and participate in Communities of Practice.
• Guide supplier audit/AVL, material qualification, procurement and change control.
• Track material controls metrics and trends.

Skills

Project management

Technical writing

Cross-functional leadership

Communication

Process improvement

Education

Bachelor's degree in Engineering

Master's degree

Job description

Boston Scientific is seeking a Senior Quality Systems Engineer for material controls to bolster quality initiatives across global sites. You will lead cross-functional projects, drive CAPAs, and ensure compliance with FDA 21 CFR Part 820 and ISO 13485, while aligning with global sourcing.

The role requires 25% travel and a strong background in supplier quality and regulatory environments. The position is hybrid, based in Arden Hills, MN, with opportunities to influence process ownership, audits,