Global Post-Market Quality Engineer - Intake Lead

Boston Scientific; Marlborough (MA); On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Engineer to provide quality engineering support for manufacturing and product development, ensuring top-quality products for patients. You will partner with cross-functional teams to improve processes, strengthen quality systems and support the development of innovative medical technologies.

As a senior technical contributor, you will lead quality initiatives across the product life cycle and drive improvements while ensuring compliance with global

Qualifications

• Bachelor's degree in engineering, science or related technical discipline.
• 5+ years' experience in a regulated manufacturing industry.
• Experience supporting quality systems, complaint handling, post-market surveillance or manufacturing quality.
• Experience leading or supporting CAPA investigations and root cause analysis.
• Experience performing risk analyses and failure mode and effects analyses (FMEAs).
• Experience interpreting and applying quality system and regulatory requirements within a regulated industry.
• Experience collaborating with cross-functional teams to support manufacturing, product development or quality improvement initiatives.

Responsibilities

• Provide quality engineering support for manufacturing and new product development to ensure products meet customer, regulatory and business requirements.
• Develop and implement product quality plans, product specifications, quality specifications, risk analyses and FMEAs in collaboration with cross-functional product development teams.
• Serve as a subject matter expert for the complaint intake process within the global complaint handling system, supporting process execution, continuous improvement and regulatory compliance.
• Monitor and evaluate global complaint records from multiple complaint sources and designated reporting locations to ensure timely and accurate event intake.
• Lead or support global strategic quality initiatives as a project owner, subject matter expert or cross-functional team member.
• Own and participate in nonconformance evaluations and corrective and preventive action (CAPA) activities to drive effective issue resolution and continuous improvement.
• Develop quality tools, procedures and training materials that promote consistent application of quality system requirements and best practices.
• Evaluate the effectiveness and compliance of quality systems, operations and manufacturing practices against applicable regulations and internal procedures.
• Support internal and external audits, including serving as the quality representative during audit activities.
• Apply analytical and systematic problem-solving methodologies to identify risks, investigate complex quality issues and implement sustainable solutions.
• Partner with cross-functional teams to improve quality, reduce risk and drive operational excellence.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality Policy and all documented quality system requirements.

Skills

Quality engineering

CAPA investigations

Root cause analysis

Risk management

FMEA

Regulatory requirements

Cross-functional collaboration

Product development support

Quality systems

Complaint handling

Education

Bachelor's degree in engineering/science

5+ years in regulated manufacturing

Tools

Minitab

Excel

CQE certification (ASQ)

Job description

Boston Scientific is seeking a Senior Quality Engineer to provide quality engineering support for manufacturing and product development, ensuring top-quality products for patients. You will partner with cross-functional teams to improve processes, strengthen quality systems and support the development of innovative medical technologies.

As a senior technical contributor, you will lead quality initiatives across the product life cycle and drive improvements while ensuring compliance with global