Boston Scientific · 1 month ago
Sr Quality Systems Engineer - CAPA
Maple Grove, MN
Full-time
Hybrid
Mid, Senior Level
$83K/yr - $157K/yr
5+ years expBoston Scientific is a company focused on enhancing communication and visibility of quality initiatives. The Sr. Quality Systems Engineer will support the CAPA program, ensuring compliance with CAPA processes, medical device regulations, and company requirements while mentoring teams and assessing CAPA records.
Health CareMedicalMedical Device
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
Qualification
Required
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
Preferred
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
Benefits
Core and optional employee benefits offered by Boston Scientific (BSC)
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
H1B Sponsorship
Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-13
2026-01-13
Company data provided by crunchbase