Supplier QA Engineer II - External Operations ENDO

Boston Scientific; Marlborough (MA); Hybrid; USD 75,000 - 143,000; Full time

Job summary

Boston Scientific’s External Operations organization seeks a Supplier Quality Engineer II to oversee supplier quality for SFMD products, including single-use devices and capital equipment. The role is based in Marlborough, MA with a hybrid schedule and 3 onsite minimum days, reporting to the Marlborough site.

Responsibilities include leading supplier audits, coordinating CAPA and change actions, and collaborating with cross-functional teams to uphold regulatory standards and quality systems.

Qualifications

• BS degree in engineering; 1+ years in supplier interaction, quality systems, or regulated processes.
• Experience in regulated industries (medical device, automotive, etc.).
• Ability to influence cross-functional global teams (Quality, Operations, R&D, Sourcing).
• Experience with process validation, design controls, risk management, CAPA, SCAR.
• Willingness to travel up to 25%.

Responsibilities

• Evaluates and communicates quality issues to suppliers and applies problem-solving methodologies.
• Proactively assesses supplier capabilities through on-site visits and discussions.
• Plans and leads supplier audits for regulatory compliance and internal requirements.
• Manages sustaining quality issues, change impacts, and design changes for suppliers.
• Investigates non-conformances from incoming inspection at distribution centers.
• Supports Design Quality Assurance with post-market signals and product inquiries.
• Investigates complaints and manages NCEPs at OEM/CM suppliers and other suppliers.

Skills

Supplier QA

Project management

Process validation

CAPA

Auditing

Education

BS in Engineering

Tools

PLM

ERP

Job description

Supplier Quality Engineer II – External Operations ENDO

Remote Eligible: Hybrid

Onsite Location(s): Marlborough, MA

About The Role

Boston Scientific'shybrid workplace incorporates an onsite 3 day minimum with optional 2 remote days. By applying to this position, you will be located and reporting to the corporate site in Marlborough, MA.

The 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 II will demonstrate a 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 within Endoscopy division with a primary focus on Single-Use Devices and Capital Equipment. Additionally, the resource will support medical and non-medical accessories or products.

Your Responsibilities Include

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, 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.
• Manages sustaining quality issues, 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.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
• Supports Design Quality Assurance with post market signals, Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
• Investigates complaints and manages NCEPs at OEM suppliers, CM suppliers and other categories of suppliers where the issue is manufacturing-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.
• Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.
• Leads and/or supports continuous improvement opportunities to drive efficiency and effectivity at BSC points of use.

New Product Development

• Execute 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, and process validations.

Quality 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.

Minimal Qualifications

• BS degree in engineering with minimum of 1+ years of relevant experience in supplier interaction, quality systems, or regulated processes.
• 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.
• 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 to 25%.

Preferred Qualifications

• Fluent in Mandarin
• MS Degree in engineering
• 5+ years of medical device engineering experience preferred, in a design, manufacturing or supplier quality related role.
• Medical Device Industry experience
• 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, CBA, SSGB, SSBB) desired.
• Working knowledge of EU MDR, FDA QMSR, IEC 60601, and ISO 14971

Requisition ID: 636871

Minimum Salary: $ 75100

Maximum Salary: $ 142600

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—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.