Boston Scientific · 3 weeks ago
Principal Quality Systems Engineer
Arden Hills, MN
Full-time
Onsite
Senior Level, Lead/Staff
$99K/yr - $188K/yr
7+ years expBoston Scientific is a leader in medical science committed to solving important health industry challenges. The Principal Quality Systems Engineer supports the development and maintenance of global quality assurance policies and processes, ensuring compliance with established standards and agency guidelines while collaborating with global quality management to implement improvements.
Health CareMedicalMedical Device
Responsibilities
Support the sub-process stewards in development and maintenance of process metrics and/or methods, as required, for performance, continous improvement, and monitoring for the Process Acceptance and Control processes
Support continuous improvement through the Quality System Steward and Community of Practice model against strategic roadmap plans of activities
Implement training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture
Review and assess changes to standards and regulations applicabe the Production and Process Control processes for potential impact to BSC and initiate projects, as needed, to ensure continued compliance
Support or oversee quality projects of major magnitude and scope. Provide input and oversight to overall quality project portfolio and project priorities
Support external audit front rooms and back rooms, training for SME’s, creation of storyboard material and site level support for global procedures
Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal
Act as a CAPA owner for corrective actions necessary to improve the global processes as appliable within the global processes
Qualification
Required
Minimum of a Bachelor's degree
Minimum of 7 years experience in relevant field(s) related to medical device quality systems and/or production and process control or equivalent
Understanding of regulations and standards applicable to the BSC Global Quality System and Process Validation and Production Control (ISO 13485, 21 CFR 820, EU MDR, etc.)
Preferred
Understanding of specific regulations and standards applicable to BSC Global Quality System and Process Validation and Production Control (ISO 14971, ISO 11607, 21 CFR 210/211, etc.)
Experience with enterprise control systems (e.g. Siemens' Manufacturing Execution System, Product Data Management-Windchill, etc.)
Excellent interpersonal skills, including strong presentation skills
Demonstrated inclusive leadership skills
Strong analytical skills
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