Hybrid CAPA: Quality Systems Engineer II

Boston Scientific Corporation; Maple Grove (MN); Hybrid; USD 72,000 - 136,000; Full time

Job summary

Boston Scientific Corporation in Maple Grove, MN is seeking a Quality Systems Engineer II to support the CAPA process, investigations, and nonconformances within a hybrid work model requiring three days in the local office weekly.

You will mentor CAPA teams, ensure robust documentation, and drive continuous improvement while aligning with FDA, ISO 13485 and global CAPA standards. The role focuses on risk-based decisions and cross-functional collaboration across site leadership.

Qualifications

• Minimum of 2 years' experience in the medical device or pharmaceutical industry.
• Understanding of regulations/standards such as 21 CFR 820 and ISO 13485.
• Experience leading or supporting cross-functional initiatives or projects.
• Strong problem-solving and root cause analysis skills.
• Strong communication and stakeholder management skills.
• Ability to make sound, risk-based decisions.
• Preferred: 2+ years in Quality Systems and/or CAPA Management.
• Preferred: collaboration across Quality, Manufacturing, Engineering, Regulatory, and Supply Chain.

Responsibilities

• Mentor cross-functional CAPA teams on root cause analyses and corrective actions.
• Coordinate activities using project management best practices and monitor CAPA timelines.
• Create robust, compliant records in the electronic CAPA database.
• Guide on nonconformance investigations including containment and risk assessments.
• Assess CAPA activities for compliance with FDA, ISO 13485, and global CAPA processes.
• Apply systematic problem-solving to identify, prioritize, and resolve quality issues.
• Support standardization and adoption of best practices across sites.
• Track CAPA metrics and trends for site program effectiveness.
• Contribute to site, regional, and global CAPA initiatives and continuous improvement.

Skills

CAPA management

Root cause analysis

Regulatory compliance

Cross-functional collaboration

Project management

Mentorship

Tools

CAPA database

Job description

Boston Scientific Corporation in Maple Grove, MN is seeking a Quality Systems Engineer II to support the CAPA process, investigations, and nonconformances within a hybrid work model requiring three days in the local office weekly.

You will mentor CAPA teams, ensure robust documentation, and drive continuous improvement while aligning with FDA, ISO 13485 and global CAPA standards. The role focuses on risk-based decisions and cross-functional collaboration across site leadership.