Supplier Quality Engineer III - External Operations ENDO

Boston Scientific•Georgetown, MA

11d•$82,100 - $156,000•Hybrid

About The Position

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 III 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.

Requirements

BS degree in engineering with minimum of 3+ 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%.

Nice To Haves

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

Responsibilities

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.
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.
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.