Boston Scientific · 17 hours ago
Principal Quality Systems Engineer
Arden Hills, MN
Full-time
Hybrid
Senior Level, Lead/Staff
$102K/yr - $194K/yr
7+ years expBoston Scientific is a leader in medical science dedicated to solving important health industry challenges. The Principal Quality Systems Engineer will support the Global Capital Equipment CAPA team, providing mentorship and ensuring compliance with internal procedures and global regulatory requirements.
Health CareMedicalMedical Device
Responsibilities
Provides guidance to GCE CAPA portfolio management ensuring a high-quality standard and in line with applicable Management Review metrics
Acts as a CAPA mentor for corrective actions necessary to improve the global CAPA, NCEP and PIR processes as appliable
Guide NCEP and CAPA teams, from a technical perspective, through risk assessment, correction, structured root cause analysis and corrective actions
Remains current on all quality systems regulations for all regulatory agencies related to the CAPA Pillar
Mentors Capital Equipment CAPA, NCEP and PIR Stewards to create and champion improvement in the CAPA Pillar and all related SOP’s and business processes
Acts as a resource and mentor for colleagues with less experience
Support and potentially lead Service Quality internal audits as needed. Provide guidance and expertise regarding audit strategies and approaches
Solves complex and diverse problems, takes a new perspective on existing solutions and exercises judgment based on the analysis of multiple sources of information using specialized knowledge of various alternatives and their impact on the business
Works independently within broad guidelines and policies, receives minimal guidance
Supports and provides guidance towards training, technical tools and driving continuous improvement and efficiencies to support a preventive quality culture
Act as a thought leader in applying the intent of regulations, not just procedural compliance
Explains difficult or sensitive information to facilitate productive discussion; works to build consensus
Regularly leads discussions and makes presentations in cross-functional meetings, effectively presenting information to explain recommendations and implications
Qualification
Required
Bachelor's degree in relevant field
7+ years CAPA/NCEP or equivalent experience
Proven leadership success through direct or indirect supervisory experience or experience leading cross-functional teams, implementing strategies, and achieving measurable results
Understanding of regulations and standards applicable to the BSC Global Quality System and CAPA, NCEP and PIR processes (ISO 13485, 21 CFR 820, EU MDR, etc.)
Experience with CAPA and CAPA concepts
Preferred
Master's degree in Engineering, Quality, or related technical discipline
Quality system experience in the medical device industry
Strong working knowledge of FDA QSR, ISO 13485, ISO 14971, and post-market requirements
Strong verbal, written communication skills, both technical and conversational
Experience supporting or leading audits and interacting with auditors as a CAPA/quality SME
Experience collaborating with international regions
Benefits
Annual bonus target
Long-term incentives
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
$10.01B2025-02-21Post Ipo Debt· $1.57B
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
WSJ.com: US Business
2026-02-05
2026-02-05
2026-02-05
Company data provided by crunchbase