Boston Scientific · 2 days ago
Principal Quality Systems Engineer
Arden Hills, MN
Full-time
Onsite
Senior Level, Lead/Staff
$102K/yr - $194K/yr
9+ years expBoston Scientific is a global leader in medical devices, and they are seeking a Principal Quality Systems Engineer to support their Global Quality Systems team. This role involves managing quality system certificates, overseeing audit processes, and providing guidance on complex quality system projects to ensure compliance with regulations and standards.
Health CareMedicalMedical Device
Responsibilities
Key responsibilities include maintaining quality system certificates to site responsibilities, assessing quality system changes for reportability and certificate changes and managing the complexities of BSC’s growth and acquisition integration
Manage and oversee critical Notified Body relationships for BSC headquarters, which includes assistance with audit scheduling, audit management, communication of quality system changes and relationship management to ensure a strong partnership between Boston Scientific and the Notified Body
Support internal and external audits and audit responses on an as needed basis, as both a subject matter expert and as the liaison for the Notified Body
Provide guidance and direction to cross functional teams seeking input on complex Quality System projects and requests, such as implementation of a large scale regulation, site expansion or transfer, etc
Lead and project manage internal and external audits and audit responses on an as needed basis
Own NCEP and CAPA records as applicable to the role
Provides direction, coaching, and mentoring for other team members
Proactively investigates, identifies, and implements process improvements, preventive CAPAs and VIPs
Regularly leads discussions and makes presentations in cross-functional meetings, effectively presenting information to explain recommendations and implications
Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Qualification
Required
Minimum bachelor's degree in science and/or engineering
9+ years medical device/quality system experience (or a master's degree in science and/or engineering and 7+ years of medical device/quality system experience)
Project management leadership: ability to create and manage a project through execution independently and ability work cross functionally to manage deadlines
Strong communication and presentation skills
Understanding and working knowledge of applicable regulations and standards, including EU Medical Device Regulation (EU) 2017/745, ISO 13485, MDSAP, 21 CFR
Ability to develop effective, positive interpersonal relationships
Demonstrated competency working cross functionally and globally
Proficiency with Microsoft Office suite, including SharePoint
Preferred
Experience with managing and updating notified body certificates
Experience working with notified bodies and audit support
Driven, energetic, self-assured professional with high personal integrity
Experience writing and implementing quality system procedures
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
BioWorld Financial Watch
2025-12-25
2025-12-12
Company data provided by crunchbase