Sr Quality Systems Engineer - CAPA

bostonscientific • Maple Grove, MN

3d • $82,600 - $156,900 • Hybrid

About The Position

The Sr. Quality Systems Engineer acts as the Quality representative to enhance communication and visibility of quality initiatives, supporting departmental, site, divisional and corporate goals. This role focuses specifically on supporting the CAPA program at Maple Grove, ensuring compliance with CAPA processes, medical device regulations, and company requirements. The position is hybrid, based in Maple Grove, MN, with 3 days per week in the office.

Requirements

• Bachelor’s degree with 5+ years, or Master’s degree with 3+ years, in medical device manufacturing, quality, or regulatory/compliance.
• Understanding of quality system requirements as stated in 21 CFR Part 820 and ISO 13485.
• Strong technical writing, documentation, and analytical skills.
• Attention to detail and risk-based decision-making.

Nice To Haves

• Degree in Science or Engineering.
• 5+ years in Quality Systems and/or CAPA management.
• Training/certification in ISO 13485 and FDA QSR (21 CFR Part 820).
• Proficiency in Power BI and Tableau.
• Proactive able to work independently, as a team leader or member, and enjoy being part of a highly visible team.
• Project management experience
• A passion for continuous improvement.

Responsibilities

• Act as CAPA subject matter expert at Maple Grove, providing guidance and making sound decisions on how to best apply the processes efficiently, effectively and compliantly.
• Mentor CAPA teams (both cross-functional and direct team members) with applying tools in root cause analysis, problem-solving methodologies, corrective action plans, effectiveness verifications and project management activities.
• Skilled at identifying, prioritizing, communicating and resolving systematic quality issues
• Providing continuous and rigorous assessment of CAPA records to ensure they are robust, compliant with BSC processes and regulations (FDA, ISO 13485 and Medical Device Requirements), and timely throughout the CAPA lifecycle.
• Determining and tracking actionable CAPA metrics and trends to assess program effectiveness and influence key stakeholders’ engagement
• Support site and global CAPA initiatives and continuous improvement projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees