Lead Quality Engineer, Medical Devices & CAPA

Boston Scientific Corporation; Maple Grove (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific Corporation in Minnesota is seeking a Principal Quality Engineer to provide technical quality engineering expertise across product development, design changes, manufacturing operations and quality systems. This hybrid role at Maple Grove/Arbor Lakes involves mentoring teams and driving quality initiatives.

The position requires a Bachelor's degree in engineering or related field and 5+ years in regulated industries, with experience in CAPAs, risk management, and quality

Qualifications

• Bachelor's degree in engineering, science, health sciences or a related field.
• Minimum of 5 years' experience in the medical device, pharmaceutical or a similarly regulated industry.
• Minimum of 5 years' experience working with quality systems and controlled processes.
• Experience coordinating or managing CAPAs and quality investigations, including initiating and managing design changes.

Responsibilities

• Apply advanced quality engineering principles to products, processes and sites, guiding implementation to meet internal and external quality and regulatory requirements.
• Lead departmental and cross-functional engineering initiatives, providing technical direction, coaching and mentoring to engineering and quality teams.
• Proactively identify, evaluate and implement best-in-class quality engineering practices, processes and systems.
• Develop and implement effective process and design control systems to support product development, qualification and ongoing manufacturing.
• Serve as a quality subject matter expert (SME) in applying ISO 14971 risk management principles across product development, clinical investigations, design changes, commercialization and post‑market activities.
• Lead or independently review risk management plans, hazard analyses, failure mode and effects analyses (FMEAs), benefit‑risk assessments, risk management reports and associated documentation.
• Ensure appropriate identification and documentation of hazards, foreseeable sequences of events, hazardous situations, harms, risk controls and residual risks.
• Assess the implementation of risk control measures and verify their effectiveness in mitigating identified product risks.
• Evaluate new information from complaints, CAPAs, nonconformances, clinical investigations and post‑market surveillance to determine potential impacts on existing product risks.
• Lead the implementation and continuous improvement of quality assurance processes, process controls and CAPA systems to meet or exceed internal and external requirements.
• Support cross‑functional quality decisions and initiatives, applying systematic problem‑solving methodologies to identify, prioritize, communicate and resolve quality issues.
• Drive the development and execution of efficient business processes and quality systems that enable timely identification and resolution of quality issues.
• Partner with management to recommend and implement improvements to quality systems, processes and overall operational effectiveness.

Skills

Quality engineering

CAPA management

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Job description

Boston Scientific Corporation in Minnesota is seeking a Principal Quality Engineer to provide technical quality engineering expertise across product development, design changes, manufacturing operations and quality systems. This hybrid role at Maple Grove/Arbor Lakes involves mentoring teams and driving quality initiatives.

The position requires a Bachelor's degree in engineering or related field and 5+ years in regulated industries, with experience in CAPAs, risk management, and quality