Supplier QA Engineer II - External Operations ENDO

Recruiter: Spencer Gregory HaleSupplier Quality EngineerII–External OperationsENDOBoston Scientific's hybrid workplace incorporates an onsite 3 day minimum with optional 2 remote days. By applying to this position, you willbelocatedandreporting to thecorporate site in Marlborough, MA.Remote Eligible: HybridOnsite Location(s): Marlborough, MAAbout the role:TheExternal Operations organization focusesonSourced Finished Medical Device (SFMD) at Boston Scientificandis a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality EngineerIIwilldemonstratea primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes. In this role, you will support SFMD products withinEndoscopydivision with a primary focus onSingle-Use Devices andCapitalEquipment. Additionally, the resource will support medical and non-medicalaccessoriesorproducts.Your responsibilities include:Sustaining Engineering:Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies inidentifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.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.Managessustaining quality issues, process change impacts, and design change implementations for supplierswithin theBSCquality system requirementsas well as supporting any requirements from thesupplier’sQuality system.Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.SupportsDesign Quality Assurance withpost market signals,Field Action and Product Inquiry Reports byperforming investigations on supplier-related or supplier-caused quality issues.Investigates complaintsand manages NCEPsat OEM suppliers,CMsuppliersand other categories of supplierswhere the issue ismanufacturing-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.Leadsprojects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part ofprojectplanning process.Leadsand/orsupportscontinuous improvement opportunities to drive efficiency andeffectivityat BSC points of use. New Product Development:Execute SFMD Plan deliverables for integrationand/or onboardingof supplier and relatedproductsinto BSC’s Quality System.Leadthe 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,componentqualifications, design verification/validations, and process validations.Quality System Champion:SupportsMaterial Controlsexternal regulatory bodyaudits requests asrequired.Leads or supportsMaterial Controlsinternal auditefforts. Collaborates with corporate and regionalsupplierquality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.Identifiesandadvisesmanagement on potential improvements to quality systems and processes in the company.Champions 100% compliance to company policies andSOP’s.What we’re looking for in you:Minimal Qualifications:BS degree in engineering withminimum of1+years of relevant experiencein supplier interaction, quality systems, or regulated processes.Experience in medicaldevice, automotive, aeronautical,semiconductor, or other regulatedindustry.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 to25%. Preferred Qualifications:Fluent in MandarinMS Degree in engineering5+ years of medical device engineering experience preferred, in a design, manufacturing or supplier quality related role.Medical Device Industry experienceProblemSolving and Project Management experienceLeadership experienceona materials or service commodity team.Lead auditor of quality systems experience (ISO 13485 or similar).ASQ certification (CQE, CBA, SSGB, SSBB)desired.Working knowledge of EU MDR, FDA QMSR, IEC 60601, and ISO 14971Requisition ID:636871Minimum Salary:$75100Maximum Salary: $142600The 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 specificprohibited substancetest 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.