Sr. Supplier Quality Engineer

bostonscientific • Marlborough, MA

4d • $86,600 - $164,500 • Onsite

About The Position

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to implement new procedural requirements in association with a new supplier relationship type. Work Mode: At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model, requiring employees to be in our local office at five days per week.

Requirements

• BS degree in engineering or related technical field with 6+ 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, and CAPA.
• 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).

Nice To Haves

• 8+ years of medical device engineering experience preferred.
• Experience driving large scale procedural updates.
• 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) strongly desired.
• Medical Device OEM Supplier Quality Management is a plus

Responsibilities

• Quality Management System Support Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents. Coordinates overall quality system project by tracking progress on project implementation, driving meetings to ensure timely completion and review, and developing communications for QMS updates
• Support on-going CAPA(s) and associated QMS implementation. Drive synergy in approach between QMS initiatives. Identifies and advises management on potential improvements to quality systems and processes in the company. Champions 100% compliance to company policies and SOP’s.
• Sustaining Engineering: 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 Acquired Entity Quality system, the hybridized BSC-Acquired Entity Quality System, and in the BSC Quality System after products are successfully integrated. Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers. Supports Design Quality Assurance with 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 and CM 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 initial onboarding deliverables to support initial distribution of Acquired Entity’s products through BSC Distribution Centers. Execute SFMD Plan deliverables for integration of acquired company’s suppliers and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees