Supplier Quality Engineer II - External Operations (SFMD)

Boston Scientific•Arden Hills, MN

2d•$71,500 - $135,800

About The Position

External Operations at Boston Scientific manages a global network of suppliers that manufacture Sourced Finished Medical Devices (SFMD) for distribution worldwide. The Supplier Quality Engineer II (SQE II) plays a critical role in ensuring patient safety, product quality, and regulatory compliance by partnering with internal cross‑functional teams and external suppliers. In this role, the SQE II will support SFMD products from the Relievant acquisition in Neuromodulation, focusing on single-use devices and equipment accessories. The position serves as a supporting contributor for supplier quality tasks and continues to develop skills in supplier oversight and quality systems.

Requirements

Bachelor’s degree in engineering or a related technical field.
3–5 years of relevant experience in supplier quality, manufacturing, quality engineering, or a regulated industry environment.
Experience working within regulated industries such as medical devices, automotive, aerospace, or semiconductor manufacturing.
Working knowledge of quality system elements including process validation, design controls, risk management, CAPA, and Supplier Corrective Action processes.
Demonstrated ability to manage quality issues and projects while influencing cross‑functional teams across Quality, Operations, R&D, and Sourcing.
Strong organizational skills with the ability to manage multiple priorities independently.
Effective written and verbal communication skills, with the ability to tailor information to technical and non‑technical audiences.
Ability to quickly learn and utilize enterprise systems and software tools (e.g., PLM, ERP, quality systems).
Willingness and ability to travel domestically and internationally up to approximately 25%.

Nice To Haves

3+ years of medical device industry experience.
Experience supporting supplier audits or participating as an audit team member (ISO 13485 or similar).
Demonstrated problem‑solving and project management experience in a supplier‑facing role.
Exposure to cross‑functional leadership or informal team leadership responsibilities.
ASQ or other quality‑related certification (e.g., CQE, CBA, Six Sigma Green Belt).

Responsibilities

Evaluate, communicate, and resolve supplier quality issues using structured and systematic problem‑solving methodologies.
Review and approve supplier corrective action plans (SCARs) and verify effectiveness through documented evidence.
Assess supplier manufacturing capabilities through on‑site visits and technical discussions; support evaluation of proposed supplier process or design changes.
Plan and execute supplier audits to assess compliance with regulatory requirements and Boston Scientific standards, including observation review, reporting, and follow‑up actions.
Manage sustaining quality issues, supplier process changes, and design change implementations in alignment with Boston Scientific and supplier quality systems.
Investigate and resolve nonconformances related to incoming inspection, product realization, performance, and audit findings.
Support Design Quality Assurance activities by investigating supplier‑related issues associated with complaints, product inquiries, and field actions.
Investigate manufacturing‑related complaints and manage nonconforming events (e.g., NCEPs) at OEM and Contract Manufacturer suppliers.
Support Supplier Change Impact Assessments for process or manufacturing changes.
Update and maintain Finished Goods Documentation to support design changes, labeling updates, and sustaining activities.
Support development and execution of inspection plans for finished devices at Boston Scientific Distribution Centers.
Contribute to project planning, milestone execution, and risk mitigation activities; support cross‑functional project teams as needed.
Support execution of SFMD Plan deliverables for onboarding new suppliers, products, or acquired businesses into the Boston Scientific Quality System.
Collaborate with cross‑functional NPD teams to support finished medical device supplier onboarding and qualification activities.
Generate, review, and support approval of quality plans, supplier agreements, product specifications, component qualifications, and design/process validation documentation.
Support initial supplier assessments, new manufacturing location qualifications, and supplier approval activities.
Support internal and external audit activities, including preparation and response to audit observations as assigned.
Collaborate with corporate and regional supplier quality teams on the development, implementation, and improvement of quality policies, procedures, and guidelines.
Identify opportunities for quality system, process, and supplier performance improvements and communicate recommendations to leadership.
Champion compliance with Boston Scientific policies, procedures, and regulatory requirements.