Quality Systems Engineer II - CAPA
About The Position
The Quality Systems Engineer II supports the Corrective and Preventive Action (CAPA) process at Boston Scientific’s Maple Grove site, including nonconforming events. The role helps ensure CAPA process compliance with internal requirements and external regulations and supports CAPA investigations and product, material, and system nonconformances. It partners with CAPA team members, investigation owners, and site leadership, and mentors Quality team members and cross-functional stakeholders on high-quality investigations, root cause identification, and sustainable corrective and preventive actions. The position follows a hybrid work model, with employees required to be in the local office at least three days per week. Boston Scientific states that it will not provide employment visa sponsorship or relocation assistance for this position. The role is safety-sensitive, and candidates are subject to a prohibited substance test as a requirement.
Requirements
- Bachelor’s degree.
- At least 2 years of experience in the medical device or pharmaceutical industry.
- Practical understanding of nonconformance and CAPA regulatory requirements and best practices.
- Understanding of regulations and 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.
Nice To Haves
- At least 2 years of experience in Quality Systems and/or CAPA Management.
- Strong interpersonal skills and ability to collaborate across Quality, Manufacturing, Engineering, Regulatory, and Supply Chain functions.
- High attention to detail, organizational skills, and a disciplined approach to compliance and documentation.
- Ability to prioritize tasks effectively in a deadline-driven environment.
- Proactive problem solver with a continuous improvement mindset.
- Ability to manage priorities in a fast-paced environment with strict regulatory timelines.
- Hands-on project management experience.
- Ability to work independently and as a contributing team member.
- Passion for Quality and a continuous improvement mindset.
Responsibilities
- Mentor cross-functional CAPA teams on root cause analysis, corrective action plans, and effectiveness verifications.
- Coach CAPA teams in project-management practices for coordinating activities, communicating progress, collaborating on deliverables, and meeting CAPA phase timelines.
- Guide teams in creating robust, compliant, and timely records in the electronic CAPA database system.
- Provide guidance on nonconformance investigations, including scoping, risk assessments, corrections, and material or product containment, such as physical segregation and identification.
- Assess CAPA activities and review documentation throughout the CAPA lifecycle for compliance with global BSC CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues.
- Contribute as a team member or leader in supporting quality disciplines, decisions, and practices.
- Partner with cross-functional stakeholders to promote standardization and adoption of best practices across sites.
- Serve as a subject matter expert team member for CAPA at the Maple Grove site.
- Track actionable CAPA metrics and trends to support execution and effectiveness of the site CAPA program.
- Support Site, Regional, and Global CAPA initiatives, continuous improvement opportunities, and projects.
- Drive continuous improvement and efficiencies to support a preventive quality culture.
Benefits
- Core and optional employee benefits are referenced; specific benefits are not listed.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
