Supplier Quality Engineer III

SUPPLIER QUALITY ENGINEER III – Electrophysiology External Operations

Recruiter:
Spencer Gregory Hale

Hybrid work model requires presence in the local office at least three days per week. No sponsorship for employment visa. No relocation assistance.

• Core team member to support product launch through execution of 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, process validations, and incoming inspection requirements.
• Lead and support initial onboarding assessments, new manufacturing locations and supplier’s approved status.

• Responsible for ongoing supplier qualification and performance monitoring based on supplier risk. Assess suppliers for technical, quality and manufacturing capabilities.
• Plan and lead supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling, investigation, evaluation of audit observations and findings, reporting, follow‑up and confirmation of follow‑up actions.
• Assess and drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Commercial Sourcing, Design Assurance.
• Investigate and solve non‑conformances due to product realization, product performance, incoming inspection, audit findings and field failures related to supplier materials. Develop corrective action plans where necessary. Apply sound, systematic problem‑solving methodologies in identifying, prioritizing and resolving quality issues. Review and approve supplier corrective action plans and verification of effectiveness documentation.
• Support supplier change impact assessments, 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.
• Maintain quality record ownership requiring technical writing skill set to formally document investigations, testing and verification of effectiveness actions utilizing statistical and industry standard quality tools.

• Support Material Controls external regulatory body audit requests as required.
• Lead or support Material Controls internal audit efforts.
• Collaborate with corporate and regional supplier quality organizations on policy, procedure and guideline development. Includes generation, review and implementation of these documents.
• Identify and advise management on potential improvements to quality systems and processes in the company.
• Champion 100% compliance to company policies and SOPs.

• Minimum of a BS degree in engineering or technical field.
• 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.
• Domestic and international travel up to 25%.

• 3+ years of medical device engineering experience preferred.
• 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, SSGB, SSBB) desired.
• 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).

Requisition

Minimum Salary: $78,300

Maximum Salary: $148,800

Estimated compensation will vary based on location and other factors. Variable compensation may include…