What are the responsibilities and job description for the Engineer Sr, Quality Production Support position at Terumo Neuro?
Job Description
Support the manufacture of medical devices. Work with Manufacturing and R&D Engineering teams to support manufacturing process changes, resolve product quality issues, and support the implementation of new products. Job duties:
US - United States
Support the manufacture of medical devices. Work with Manufacturing and R&D Engineering teams to support manufacturing process changes, resolve product quality issues, and support the implementation of new products. Job duties:
- Work with Manufacturing Engineers on process improvement and cost reduction projects.
- Resolve product quality issues and manages non-conformance investigations and corrective actions.
- Lead/manage QAR/CAPA projects as assigned.
- Work with Supplier Quality Manager/Engineers to maintain high quality level of incoming production materials.
- Support process validation by developing or reviewing test protocols and reports.
- Support equipment qualifications by reviewing equipment specifications, IQ/OQ reports and unscheduled maintenance reports.
- Support internal and external audits by participating preparation activities and addressing audits findings.
- Work with R&D, Manufacturing Engineers, Regulatory, and Supply Chain Planner to support implementation of new products on Production floor.
- Work with R&D and Manufacturing Engineers to develop and update pFMEA based on non-conformance reports and complaints.
- Work with Manufacturing Engineers to perform product quality metric data analysis.
- Lead projects in improving effectiveness and efficiency of assembly inspection activities and cross-functional system-related processes.
- Perform other duties and responsibilities as assigned.
- Bachelor’s degree in Engineering or equivalent.
- Minimum of four (4) years of engineering experience in medical device manufacturing industry.
- Strong interpersonal and written and verbal communication skills.
- Proficient computer skills including MS Word, Excel, and statistical software (e.g., MiniTab, Statgraphic, Design of Experiment DOE, etc.).
- Ability to understand the technology related to MicroVention’s products.
- Advanced knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).
US - United States
