Boston Scientific Supplier Quality Engineer III - External Operations Acquisition 

United States, Massachusetts, Marlborough 

244942388

Spencer Gregory Hale

Supplier Quality Engineer III – External Operations Acquisition

Hybrid

Your responsibilities include:

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 we’re looking for in you:
Minimal Qualifications:

• BS degree in engineering or technical field with minimum of 5+ 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, 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:

• 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).

• ASQ certification (CQE, CBA, SSGB, SSBB) desired.

Maximum Salary: $ 151400

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.