Principal Quality System Engineer - CAPA

Boston Scientific•Maple Grove, MN

13d•Hybrid

About The Position

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.

Requirements

Bachelor's degree
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

Nice To Haves

Strong interpersonal skills with the ability to collaborate effectively across Quality, Manufacturing, Engineering, Regulatory, and Supply Chain functions
Ability to clearly document and communicate investigation outcomes and recommendations to technical and non-technical stakeholders
High attention to detail, organizational skills, and a disciplined approach to compliance and documentation
Proactive problem solver with a continuous improvement mindset
Ability to manage priorities in a fast-paced environment with strict regulatory timelines

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 (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