Boston Scientific · 1 month ago
Supplier Quality Engineer III - Drugs Categories
Maple Grove, MN
Full-time
Onsite
Mid, Senior Level
$76K/yr - $144K/yr
3+ years expBoston Scientific is a leading medical device company focused on transforming lives through innovative medical solutions. The Supplier Quality Engineer will lead performance improvement initiatives for active pharmaceutical ingredients and excipient suppliers, ensuring compliance with quality standards and enhancing supplier capabilities. This role involves auditing suppliers, developing acceptance criteria, and driving corrective actions to improve product quality and safety.
Health CareMedicalMedical Device
Responsibilities
Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling, investigation, and evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions. Proactively assesses supplier capabilities through direct on-site visits and technical discussions and supports the evaluation of proposed changes at suppliers
Develops solutions to complex problems by evaluating data and selecting methods within defined practices and policies. Communicates quality issues to suppliers, applies systematic problem-solving methodologies, and reviews and approves supplier corrective action plans and effectiveness documentation
Actively engaging in Global Sourcing category teams as a technical lead, establishing and executing Global Sourcing category objectives
Leads cross-divisional and cross-functional projects that deliver improvements to quality systems and processes
Works under minimal direction regarding the direction and progress of projects and special assignments. Independently determines and develops innovative approaches to solutions. Interprets, executes, and recommends modifications to the Quality Management System. Provides leadership and mentorship to junior engineers. Work is reviewed upon completion for adequacy in meeting strategic objectives and alignment with company goals
Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions
In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures. Ensure that appropriate resources, including personnel and tools, are available to support Quality System compliance and adherence to the Quality Policy. Foster a work environment that upholds the Quality Policy and Quality System
Qualification
Required
BS degree in Chemistry, Biochemistry, chemical engineering, Materials Science or similar with 3+ years of relevant experience
Communicates effectively and concisely pack up information to deliver key points; appropriately scales communication style and depth according to the audience
Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing
Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors
Ability to work independently and collaborate with project teams; organized and self-driven
Experience in global supplier management, ISO 13485, ISO 9001
Strong knowledge of FDA 21 CFR 820
Ability to work in a matrixed environment
Travel up to 10% of the time
Preferred
Experience in pharmaceutical or drug combination products
Experience with manufacturing support or process development
Experience with project management
Ideally someone with experience in aseptic processes
Knowledge of and CFR 210/211
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
Medical Device Network
2026-01-17
2026-01-17
2026-01-17
Company data provided by crunchbase