Boston Scientific · 1 month ago
Supplier Quality Engineer III - External Operations CRM/NMOD
Arden Hills, MN
Full-time
Onsite
Mid, Senior Level
$76K/yr - $144K/yr
5+ years expBoston Scientific is a global leader in the medical device industry, focusing on improving patient outcomes. The Supplier Quality Engineer III will oversee supplier quality processes, ensuring compliance and collaboration with cross-functional teams to enhance manufacturing practices for finished medical devices.
Health CareMedicalMedical Device
Responsibilities
Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation
Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers
Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions
Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the BSC quality system requirements as well as supporting any requirements from the supplier’s Quality system
Investigates and solves non-conformances due to product realization, product performance, incoming inspection, audit findings, etc
Supports Design Quality Assurance with post market surveillance, trending Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues
Investigates complaints, defines complaint management processes and manages NCEPs at OEM suppliers, CM suppliers and other categories of suppliers where the issue is manufacturing-related
Supports Supplier Change Impact Assessments for process changes at suppliers
Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates
Creates, defines and manages Inspection Plans for finished devices in BSC Distribution Centers
Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process
Leads and/or supports continuous improvement opportunities to drive efficiency and effectivity at BSC points of use
Execute SFMD Plan deliverables for integration and/or onboarding of supplier and related products into BSC’s Quality System
Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers
Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations
Lead and support initial on-boarding assessments, new manufacturing locations and supplier’s approved status
Supports Material Controls external regulatory body audits requests as required
Leads or supports Material Controls internal audit efforts
Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents
Identifies and advises management on potential improvements to quality systems and processes in the company
Champions 100% compliance to company policies and SOP’s
Qualification
Required
BS degree in engineering or technical field with minimum of 5+ years of relevant experience
Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry
Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing
Experience in process validation, design controls, risk management, CAPA, SCAR
Ability to work independently; organized and self-driven
Articulate communicator; adept at packaging and appropriately scaling information to the intended audience
Ability to rapidly learn and use new software applications (e.g., PLM, ERP)
Domestic and international travel up to 25%
Preferred
3+ years of medical device engineering experience preferred
Medical Device Industry experience
Problem Solving and Project Management experience
Leadership experience on a materials or service commodity team
Lead auditor of quality systems experience (ISO 13485 or similar)
ASQ certification (CQE, CBA, SSGB, SSBB) desired
Benefits
Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
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
2025-12-11
Company data provided by crunchbase