Supplier Quality Engineer II - External Operations (SFMD)

Recruiter: Spencer Gregory Hale\n\n## Supplier Quality Engineer II \u2013 External Operations (SFMD)\n\n## About the Role\n\nExternal 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\u2011functional teams and external suppliers.\n\nIn 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.\n\n## \n\n## Your responsibilities include:\n\n### Sustaining Engineering\n\n * Evaluate, communicate, and resolve supplier quality issues using structured and systematic problem\u2011solving methodologies.\n * Review and approve supplier corrective action plans (SCARs) and verify effectiveness through documented evidence.\n * Assess supplier manufacturing capabilities through on\u2011site visits and technical discussions; support evaluation of proposed supplier process or design changes.\n * Plan and execute supplier audits to assess compliance with regulatory requirements and Boston Scientific standards, including observation review, reporting, and follow\u2011up actions.\n * Manage sustaining quality issues, supplier process changes, and design change implementations in alignment with Boston Scientific and supplier quality systems.\n * Investigate and resolve nonconformances related to incoming inspection, product realization, performance, and audit findings.\n * Support Design Quality Assurance activities by investigating supplier\u2011related issues associated with complaints, product inquiries, and field actions.\n * Investigate manufacturing\u2011related complaints and manage nonconforming events (e.g., NCEPs) at OEM and Contract Manufacturer suppliers.\n * Support Supplier Change Impact Assessments for process or manufacturing changes.\n * Update and maintain Finished Goods Documentation to support design changes, labeling updates, and sustaining activities.\n * Support development and execution of inspection plans for finished devices at Boston Scientific Distribution Centers.\n * Contribute to project planning, milestone execution, and risk mitigation activities; support cross\u2011functional project teams as needed.\n\n\n\n### \n\n### New Product Development (NPD)\n\n * Support execution of SFMD Plan deliverables for onboarding new suppliers, products, or acquired businesses into the Boston Scientific Quality System.\n * Collaborate with cross\u2011functional NPD teams to support finished medical device supplier onboarding and qualification activities.\n * Generate, review, and support approval of quality plans, supplier agreements, product specifications, component qualifications, and design/process validation documentation.\n * Support initial supplier assessments, new manufacturing location qualifications, and supplier approval activities.\n\n\n\n### \n\n### Quality System \u0026 Continuous Improvement\n\n * Support internal and external audit activities, including preparation and response to audit observations as assigned.\n * Collaborate with corporate and regional supplier quality teams on the development, implementation, and improvement of quality policies, procedures, and guidelines.\n * Identify opportunities for quality system, process, and supplier performance improvements and communicate recommendations to leadership.\n * Champion compliance with Boston Scientific policies, procedures, and regulatory requirements.\n\n\n\n## \n\n## What we\u0027re looking for in you:\n\n### Required Qualifications\n\n * Bachelor\u2019s degree in engineering or a related technical field.\n * 3\u20135 years of relevant experience in supplier quality, manufacturing, quality engineering, or a regulated industry environment.\n * Experience working within regulated industries such as medical devices, automotive, aerospace, or semiconductor manufacturing.\n * Working knowledge of quality system elements including process validation, design controls, risk management, CAPA, and Supplier Corrective Action processes.\n * Demonstrated ability to manage quality issues and projects while influencing cross\u2011functional teams across Quality, Operations, R\u0026D, and Sourcing.\n * Strong organizational skills with the ability to manage multiple priorities independently.\n * Effective written and verbal communication skills, with the ability to tailor information to technical and non\u2011technical audiences.\n * Ability to quickly learn and utilize enterprise systems and software tools (e.g., PLM, ERP, quality systems).\n * Willingness and ability to travel domestically and internationally up to approximately 25%.\n\n\n\n### \n\n### Preferred Qualifications\n\n * 3+ years of medical device industry experience.\n * Experience supporting supplier audits or participating as an audit team member (ISO 13485 or similar).\n * Demonstrated problem\u2011solving and project management experience in a supplier\u2011facing role.\n * Exposure to cross\u2011functional leadership or informal team leadership responsibilities.\n * ASQ or other quality\u2011related certification (e.g., CQE, CBA, Six Sigma Green Belt).\n\n\n\nRequisition ID: 625969\n\nMinimum Salary: $ 71500\n\nMaximum Salary: $ 135800\n\nThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) \u2013 see www.bscbenefitsconnect.com\u2014will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.\n\nCompensation for non-exempt (hourly), non-sales roles 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).\n\nCompensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).\n\nFor MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.\n\nBoston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.\n\nAmong other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. \n