Boston Scientific · 17 hours ago
Senior Quality System Engineer
US-MN-Maple Grove
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $162K/yr
5+ years expBoston Scientific is a leader in medical science committed to solving health industry challenges. The Senior Quality System Engineer will be responsible for driving audit excellence and ensuring compliance with quality standards across the Maple Grove and Arbor Lakes sites.
Health CareMedicalMedical Device
No H1B
Responsibilities
Lead Maple Grove external audit preparation, execution, and closure activities, including managing nonconformance and action response processes as needed
Lead and support audit readiness strategies for both Maple Grove and Arbor Lakes sites
Serve as the primary site representative on the External Audit Global Community of Practice
Collaborate with other Boston Scientific sites to provide cross-site external audit support as needed
Execute internal audits periodically for the Maple Grove and Arbor Lakes sites
Support continued participation in the Medical Device Discovery Appraisal Program as part of FDA’s ‘Case for Quality.’
Promote a work environment that supports the Global Quality Policy, continuous improvement, and Boston Scientific’s Core Values
Serve as an effective leader or team member in support of quality disciplines, decisions, and practices
Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
Partner with internal teams to provide guidance on Boston Scientific’s Quality Management System and applicable regulations/standards
Qualification
Required
Minimum of Bachelor's degree and 5 years' experience in the medical device or pharmaceutical industry
Minimum of 2 years' experience in a Quality Systems role that includes internal or external audit support
In-depth knowledge of regulations/standards such as 21 CFR 820 and ISO 13485
Strong understanding of quality principles and interrelated job functions
Highly detail-oriented with strong analytical skills
Ability to make sound, risk-based decisions
Preferred
Proven experience managing, coordinating, or supporting external audits of medical device quality systems
Minimum of 5 years' experience in audit support (internal, supplier, notified body, or regulatory audits)
Excellent verbal and written communication, interpersonal, project management, and organizational skills
Ability to understand procedural documents and evaluate documents for compliance with applicable regulations and requirements
Ability to collaborate and communicate effectively across all levels of the organization
Ability to be proactive, work independently, and contribute to a highly visible team
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
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
2026-01-16
2026-01-16
2026-01-16
Company data provided by crunchbase