Supplier Quality Engineer III - External Operations ENDO

Supplier Quality Engineer III - External Operations ENDO

United States, Massachusetts, Marlborough

Supplier Quality Engineer III - External Operations ENDO

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.

• 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.
• Sustain and maintain the Material Controls Project Tracking Plan for recently acquired suppliers.

• Execute SFMD Plan deliverables for integration of acquired company's suppliers and products into BSC's Quality System.
• Support Supplier Selection and evaluation of replacement supplier for underperforming suppliers.
• Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard newly selected 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.

• BS degree in engineering or technical fieldwith minimum of 5+ years of relevant experience in quality engineering.
• 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%.

• 3+ years of medical device engineering experience preferred.
• 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).

Requisition

Minimum Salary:$82100

Maximum Salary: $156000

The…