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Senior Quality Assurance Engineer (Defined Term) jobs in United States
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Boston Scientific · 8 hours ago

Senior Quality Assurance Engineer (Defined Term)

Boston Scientific is a leader in medical science committed to solving important health industry challenges. The Senior Quality Assurance Engineer will utilize quality engineering methodologies to meet customer and regulatory requirements within the distribution supply chain environment, supporting new product launches and ensuring quality compliance.
Health CareMedicalMedical Device
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Responsibilities

Provide leadership by championing departmental and cross-functional engineering initiatives
Provide project direction, coaching, and mentoring for engineering and technical team members
Serve as a technical mentor for identifying and resolving quality issues, including nonconforming events and CAPA processing
Identify and implement effective process controls and systems to support the development, qualification, and ongoing distribution of products that meet or exceed internal and external requirements
Proactively investigate, identify, and implement best-in-class quality engineering practices
Lead the implementation of quality assurances, process controls, and CAPA systems to meet or exceed regulatory and customer requirements
Review, evaluate, and approve SOPs, work instructions, project plans, risk management files, and process verifications, as applicable
Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
Assure the development and execution of streamlined business systems that effectively identify and resolve quality issues
Collaborate cross-functionally with site operational teams and divisional partners to ensure quality compliance on assigned projects
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures
Engage in continuous process improvement and optimization initiatives

Qualification

Quality engineeringLean Six SigmaRoot cause analysisSAP ERPSupplier qualityProcess improvementCommunication skillsInterpersonal skillsAttention to detail

Required

Bachelor's degree in engineering or an equivalent combination of education and experience
Minimum of 5 years' experience and up to 7 years' experience in quality engineering within the medical device industry, including distribution or supply chain environments
Experience with supply chain distribution practices
Strong communication and cross-functional collaboration skills
Experience with Lean, Six Sigma, process improvement, root cause analysis, and structured problem-solving methodologies
Excellent interpersonal and relationship-building skills
Ability to travel up to 5 percent

Preferred

Experience with SAP ERP and Manhattan systems
Exposure to packaging and final pack requirements
Proven ability to influence without direct authority
Supplier quality experience
Strong attention to detail

Company

Boston Scientific

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Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.

Funding

Current Stage
Public Company
Total Funding
$10.01B
2025-02-21Post Ipo Debt· $1.57B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B

Leadership Team

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Michael Mahoney
Chairman, President & CEO
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Daniel J. Brennan
Chief Financial Officer
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Company data provided by crunchbase