Staff Engineer, Quality Production Support (NPI)
Staff Engineer, Quality Production Support (NPI)
MicroVention-Terumo
Aliso Viejo, CA
See who MicroVention-Terumo has hired for this role
Job Description
Lead Quality Engineering Projects to 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
Lead Quality Engineering Projects to 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 changes, process improvement, and cost reduction projects, potentially leading the project.
- Lead projects in improving effectiveness and efficiency of assembly inspection activities and cross-functional system-related processes.
- Lead effort to resolve product quality issues.
- Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), equipment calibration, internal auditing, and quality metrics data analysis.
- 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.
- Review component and assembly nonconformance’s and provide direction in material review board.
- Work with Supplier Quality Manager/Engineers and suppliers to maintain high quality level of incoming production materials, as necessary.
- Support process and test method validation by developing, executing, or reviewing test protocols and reports.
- Coordinate implementation of new equipment and maintenance of existing equipment by reviewing equipment specifications and related qualification (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, review, and update risk analysis documents including product risk assessments and FMEA documents such as pFMEA.
- Supervise technical activities of Technicians and Engineers involved in quality engineering.
- 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.
- Bachelor’s degree in Engineering or related field.
- Minimum of six (6) to eight (8) or more years of engineering experience in medical device or other regulated manufacturing industry.
- Strong interpersonal and written and verbal communication skills.
- Strong mathematics and proficient computer skills including MS Word, Excel, Outlook, and statistical tools including Statistical Software (e.g., MiniTab, Statgraphic, Design of Experiment DOE, etc.).
- Ability to provide technical leadership in process validation, test method validation, data analysis, risk analysis, change control, design control, design verification, and design validation.
- Strong knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).
- Ability to understand the technology related to MicroVention’s products.
US - United States
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Information Technology -
Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at MicroVention-Terumo by 2x
See who you knowGet notified about new Production Support Engineer jobs in Aliso Viejo, CA.
Sign in to create job alertSimilar jobs
People also viewed
-
R&D Mechanical Engineer(junior)
R&D Mechanical Engineer(junior)
-
Manufacturing Engineer
Manufacturing Engineer
-
Mechanical Design Engineer
Mechanical Design Engineer
-
Mechanical Engineer
Mechanical Engineer
-
Mechanical Engineer
Mechanical Engineer
-
Junior Engineer - Mechanical
Junior Engineer - Mechanical
-
Mechanical / Aerospace Engineer
Mechanical / Aerospace Engineer
-
Mechanical Engineer, Amazon
Mechanical Engineer, Amazon
-
Manufacturing Engineer
Manufacturing Engineer
-
Manufacturing Engineer
Manufacturing Engineer
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub