Supplier Quality Engineer III - Cardiac Rhythm Management

Recruiter: Spencer Gregory HaleSupplier Quality Engineer III – Cardiac Rhythm ManagementThe External Operations organization focuses on Sourced Finished Medical Device (SFMD) at Boston Scientific and is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer III will demonstrate a primary commitment to patient safety and compliance through collaboration with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes to ensure finished device quality. In this role, you will support SFMD products within the Cardiac Rhythm Management division with a primary focus on Single-Use Devices and Capital Equipment.Additionally, the Supplier Quality Engineer will support global sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects.Work model, sponsorship, relocation:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.Function or Divisional OverviewAt Boston Scientific, our products and technologies support the diagnosis and treatment of a wide range of medical conditions, with a focus on advancing less invasive care. Within the Cardiac Rhythm Management (CRM) portfolio, Boston Scientific develops, manufactures, and markets solutions designed to treat complex cardiac arrhythmias and enable precise, catheter-based interventions.The CRM portfolio includes technologies for cardiac mapping and navigation, radiofrequency ablation, diagnostic electrophysiology, CRM recording systems, and intracardiac access and steerable sheath solutions, supporting physicians across the full CRM procedure workflow. These products are designed to improve procedural efficiency, precision, and patient outcomes in the treatment of cardiac rhythm disorders.Boston Scientific continues to invest in innovation, clinical research, and global expansion within Cardiac Rhythm Management, extending access to advanced therapies across key geographies. Through ongoing portfolio development and clinical evidence generation, the CRM division supports the evolution of catheter-based treatment strategies for some of the most complex and prevalent cardiac arrhythmias.Key Responsibilities will inlcude:New Product Development: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 on-boarding assessments, new manufacturing locations and supplier’s approved statusSustaining Supplier Quality & ComplianceResponsible for ongoing supplier qualification and performance monitoring based on supplier risk. Assess suppliers for technical, quality and manufacturing capabilitiesPlans 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 actionsAssess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Commercial Sourcing, Design Assurance.Investigates & solves non-conformances due to product realization, product performance, incoming inspection, audit findings, & field failures related to supplier materials. Develop corrective action plan where necessary. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentationSupports 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.Quality record ownership requiring technical writing skillset to formally document investigations, testing and verification of effectiveness actions utilizing statistical and industry standard quality toolsQuality System Champion: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.Required Qualifications:Minimums of 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%. Preferred Qualifications:3+ years of medical device engineering experience preferred.Problem Solving and Project Management experienceLeadership experience on a materials or service commodity team.Lead auditor of quality systems experience (ISO 13485 or similar).ASQ certification (CQE, SSGB, SSBB) desiredAbility 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 ID: 634119Minimum Salary: $ 78300Maximum Salary: $ 148800The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see will 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.Compensation 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).Compensation 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).For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.Boston 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.Among 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.