Global Supplier Quality Engineer – Pharma & Compliance

Boston Scientific Gruppe; Maple Grove, Northern (MN, KY); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific Corporation in Minneapolis seeks a Supplier Quality Engineer to drive performance improvement of APIs, excipients, and supplier capabilities to meet quality standards. The role supports global sourcing, manufacturing operations, and quality systems, engaging in communities of practice and value improvement projects.

You will lead supplier audits, develop acceptance criteria, monitor performance, and guide corrective actions, with opportunities to mentor junior engineers and

Qualifications

• BS degree in Chemistry, Biochemistry, chemical engineering or similar.
• Minimum 5 years of relevant experience.
• Experience in pharmaceutical or drug products and GMP for APIs.
• Strong knowledge of FDA 21 CFR 820 and CFR 210/211.
• Ability to influence cross-functional global teams.
• Travel up to 10% of the time.

Responsibilities

• Plan and lead audits of suppliers to assess compliance with regulatory and Boston Scientific requirements.
• Proactively assess supplier capabilities through on-site visits and technical discussions.
• Develop solutions to complex problems by evaluating data and applying root-cause methodologies.
• Lead projects within the function to improve quality systems and processes.
• Mentor junior engineers and collaborate in a matrixed environment.

Skills

Quality engineering

Regulatory knowledge

Cross-functional collaboration

Project management

Education

BS degree in Chemistry, Biochemistry, chemical engineering or similar

Job description

Boston Scientific Corporation in Minneapolis seeks a Supplier Quality Engineer to drive performance improvement of APIs, excipients, and supplier capabilities to meet quality standards. The role supports global sourcing, manufacturing operations, and quality systems, engaging in communities of practice and value improvement projects.

You will lead supplier audits, develop acceptance criteria, monitor performance, and guide corrective actions, with opportunities to mentor junior engineers and