Staff Engineer, Quality (New Products)

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Join to apply for the Staff Engineer, Quality (New Products) role at Terumo Neuro

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Job Description

Production Support Focus

Lead quality engineering projects to support the manufacturing of medical devices. Work with Manufacturing and R&D in leading efforts to resolve product quality issues. Support manufacturing process changes and product design improvements.

Product Development Focus

Lead quality engineering projects to support the development of medical devices. Work with Manufacturing and R&D in leading efforts to resolve product quality issues. Work with R&D and Manufacturing to lead design control activities for the implementation of new products and product design improvements.

Job Duties Production Support

• Provide technical skill in many areas of quality engineering such as nonconformances, evaluating inspection data, evaluating process changes, implementing risk analysis, performing test method validations, and analyzing data.
• Supervise technical activities of Technicians and Engineers involved in quality engineering.
• Lead efforts to resolve product quality issues.
• Review component and assembly nonconformances and provide direction in material review board.
• Work with Manufacturing Engineers to review process changes.
• Work with suppliers to maintain high quality levels of incoming production materials.
• Conduct quality audits of suppliers.
• Coordinate and assist with first article inspections.
• Conduct or review test method validations.
• Coordinate implementation of new equipment by reviewing equipment specifications and related qualifications.
• Prepare or review risk analysis documents including product risk assessments and FMEAs.
• Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
• Largely self-directed and proactively motivated. Capable of meeting goals with minimal supervision and managing multiple concurrent projects.
• Some travel required (approximately 10%).
• Perform other duties and responsibilities as assigned.

Job Duties Product Development

Qualifications

Desired Qualifications

Posting Country

US - United States

Seniority level

Seniority level

Associate

Employment type

Employment type

Full-time

Job function

Job function

Engineering and Information Technology

Industries

Medical Equipment Manufacturing

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