Principal Quality System Engineer - CAPA

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Onsite Location(s):
Maple Grove, MN, US, 55311

Principal Quality System Engineer - CAPA

About the role:

As a Principal Quality System Engineer supporting CAPA, you will serve as a key Quality representative responsible for driving effectiveness, compliance, and continuous improvements of the Corrective and Preventive Action (CAPA) process across the Maple Grove site.

The Principal Quality Systems Engineer will be the Technical Leader representing the CAPA process to internal and external stakeholders. This includes CAPA Investigations, Product/Material/System Nonconformances, and Field Action support. This role partners closely with Site Leadership, Maple Grove CAPA team members, investigation owners, as well as Regional and Global Quality Systems personnel. They will provide mentorship to Quality team members and cross-functional stakeholders to enable high-quality investigations, robust root cause identification, and sustainable corrective and preventive actions.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• 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 (including physical segregation/identification).
• 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

Qualifications:

Required 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

Preferred qualifications:

• Strong interpersonal skills with the ability to collaborate effectively across Quality,…