Senior CAPA & Quality Systems Engineer

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

Job summary

Boston Scientific in Maple Grove, MN is seeking a Principal Quality System Engineer - CAPA to lead CAPA investigations, nonconformances, and field action support across the site. You will mentor quality teams, drive root cause analysis, and ensure effective corrective actions within a compliant quality system.

The role follows a hybrid work model with on-site presence required several days per week; relocation sponsorship is not available.

Qualifications

• Minimum of 7 years' experience in the medical device or pharmaceutical industry.
• Minimum of 5 years' experience in a Quality role that includes Nonconformance/CAPA support
• Direct experience executing, supporting, or mentoring complex CAPAs
• Practical understanding of nonconformance regulatory requirements and best practices, including material identification, labeling, and segregation
• In-depth knowledge of regulations/standards such as 21 CFR 820 and ISO 13485
• Experience supporting audits or regulatory inspections
• 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

Responsibilities

• Partner with Site Leadership to maintain and improve CAPA process, tools, and governance models
• Act as a Subject Matter Expert (SME) for the CAPA process, providing guidance on expectations, requirements, and best practices
• Monitor Nonconformance and CAPA performance metrics (e.g., timeliness, effectiveness, aging) and identify trends, gaps, and improvement opportunities
• Support development and distribution of Nonconformance and CAPA metrics for management review and quality forums
• Provide guidance on nonconformance investigations to support appropriate scoping, risk assessments, corrections, and material/product containment
• Provide guidance to CAPA owners and cross-functional teams on root cause analysis and solution development
• Provide mentorship for Site CAPAs
• Build organizational capability in Nonconformance and CAPA execution by supporting development and deployment of training and tools
• Partner with cross-functional stakeholders to drive standardization and adoption of best practices across sites
• Drive continuous improvement and efficiencies to support a preventive quality culture
• Support internal and external audits and inspections by providing Nonconformance and CAPA related documentation and subject matter expertise
• Act as a Quality System resource for external audit readiness, including field action support

Skills

CAPA experience

Quality management

Regulatory knowledge

Root cause analysis

Cross-functional collaboration

Audit support

Problem solving

Stakeholder management

Decision making

Job description

Boston Scientific in Maple Grove, MN is seeking a Principal Quality System Engineer - CAPA to lead CAPA investigations, nonconformances, and field action support across the site. You will mentor quality teams, drive root cause analysis, and ensure effective corrective actions within a compliant quality system.

The role follows a hybrid work model with on-site presence required several days per week; relocation sponsorship is not available.