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Boston Scientific · 2 hours ago

Sr. Supplier Quality Engineer

Marlborough, MA

Full-time

Onsite

Mid, Senior Level

$87K/yr - $164K/yr

6+ years exp

Boston Scientific is a global leader in the medical device industry, committed to solving significant health challenges. The Senior Supplier Quality Engineer will focus on patient safety, collaborating with various teams to ensure quality compliance and effective supplier management.

Health CareMedicalMedical Device

No H1B

Responsibilities

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

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

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

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

Qualification

Medical device experienceProcess validationQuality management systemsProject managementRisk managementCAPALead auditor experienceArticulate communicatorContinuous improvementSoftware application learningSupplier quality managementRegulatory complianceTechnical discussionsWork independentlyTeam collaborationLeadership experience

Required

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)

Preferred

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

Benefits

Variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements)

Variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements)