Supplier Quality Engineering Manager

Boston Scientific•Arden Hills, MN

18h•$102,100 - $194,000•Hybrid

About The Position

The External Operations (ExOps) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineering Manager 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 Sourced Finished Medical Device (SFMD) products within a newly acquired company, with a primary focus on Single-Use Devices, Capital Equipment, and Capital Equipment Accessories. This role is intended to support acquisitions with the Cardiac Rhythm Management, Electrophysiology, and Neuromodulation divisions. Your role will deliver improvement in supplier process capability and product performance, reducing risk related to sustaining acquired finished devices and integrating supplier and material controls into BSC standard processes. Your role will also influence the development of early-career and experienced engineers to provide stretch opportunities, guidance, and critical feedback to support the needs of the business and the growth of the engineer.

Requirements

Bachelor’s degree required in engineering, science, or another technical discipline
7+ years of progressive quality engineering experience working with functional areas across divisions/sites
Strong facilitation & communication skills with the ability to successfully interact at all levels of the organization with proven ability to lead individuals, complex projects, and solve difficult technical problems.
Highly adaptable, willing to accept new ideas, and ability to create, influence, and implement global strategies and policies successfully
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

7+ years of medical device engineering experience preferred.
Global Sourcing or Operations experience preferred
MBA, advanced degree
New Product development experience and partnering with R&D and Project Management groups
Lead auditor of quality systems experience (ISO 13485 or similar).
ASQ certification (CQE, CBA, SSGB, SSBB) desired.
Previous experience with technology and supplier acquisition & integration
Experience leading virtual teams
Experience recruiting & developing a high-performance technical team
Ability to interface with internal customers to gather insight

Responsibilities

Monitors daily work operations and provides direction and guidance to experienced exempt employees to achieve unit or project goals.
Preparation of key metrics and data to show progress and adherence to schedule and to monitor progress and improvement in the area of supplier quality.
Translates department goals into individual objectives and strategic projects.
Identifies, develops and implements processes to improve functional performance.
Monitors functional activities and records to ensure compliance through critical decision making.
Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources
Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.
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.
Execute and manage initial onboarding deliverables to support initial distribution of Acquired Entity’s products through BSC Distribution Centers.
Execute and manage 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.
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.
Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.