Boston Scientific · 1 month ago
Sr. Supplier Quality Engineer - Direct Materials Acquisitions
United States
Full-time
Remote
Mid, Senior Level
$83K/yr - $157K/yr
5+ years expBoston Scientific is a global leader in medical devices, and they are seeking a Senior Supplier Quality Engineer to enhance supplier quality processes. This role involves collaborating with suppliers to ensure compliance with quality standards and managing quality issues related to implantable products in the Cardiac Rhythm Management division.
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
Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the Acquired Entity Quality system, the hybridized BSC-Acquired Entity Quality System, and in the BSC Quality System after products are successfully integrated
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
Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues
Investigates complaints and manages NCEPs at OEM suppliers and CM 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
Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process
Support manufacturing lines of acquired entity’s manufacturing line through integration of acquired company’s suppliers and products into BSC’s Quality System
Lead the execution of material controls quality deliverables and collaborate with cross-functional new product development teams to onboard suppliers
Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations
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
7+ years of medical device engineering experience preferred
Medical Device Industry experience
Drug or animal tissue 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
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
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