Global Post-Market Quality Engineer – Intake & CAPA

Boston Scientific; Maple Grove (MN); 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 highest quality for patient safety. You will partner with cross-functional teams to improve processes, strengthen quality systems and support innovative medical technologies.

As a senior technical contributor, you will lead quality initiatives across the product life cycle, influence improvements and ensure compliance with global regulatory

Qualifications

• Bachelor's degree in engineering, science or related technical discipline is required.
• Experience in a regulated manufacturing industry is preferred.
• Experience supporting quality systems, complaint handling, post-market surveillance or manufacturing quality within a regulated industry is preferred.
• Experience leading or supporting CAPA investigations and root cause analysis.
• Experience performing risk management activities, including FMEA.

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 sources to ensure timely and accurate event intake.
• Lead or support global strategic quality initiatives as a project owner, SME or cross-functional team member.
• Own and participate in nonconformance evaluations and CAPA activities to drive issue resolution and continuous improvement.
• Develop quality tools, procedures and training materials that promote consistent quality system compliance.
• Evaluate the effectiveness and compliance of quality systems, operations and manufacturing practices against regulations and procedures.
• Support internal and external audits, including serving as the quality representative during audits.

Education

Bachelor's degree in engineering, science or related technical discipline

Tools

Minitab

Microsoft Excel

Job description

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

As a senior technical contributor, you will lead quality initiatives across the product life cycle, influence improvements and ensure compliance with global regulatory