Quality Engineer

A leader in innovative products and complete solutions in the healthcare industry is currently seeking a Quality Engineer responsible for quality evaluation and control of the product development projects in the West Sacramento, CA, area. This is a 7 month CONTRACT position, with the possibility of extension. Local candidates only. No per diem is available for this assignment.

RESPONSIBILITIES

- Work with cross-functional teams to assure their product development, design change, risk management, verification & validation activities and the resulting work products are in compliance with applicable regulations and standards
- Lead and ensure completion of Risk Management activities
- Participate in Product Life Cycle Phase Reviews

REQUIREMENTS

- Knowledge and experience in quality management of hardware and software engineering processes in compliance with 21 CFR 820 and QSIT regulations, ISO 13485 & 14971, and IEC 62366 & 62304
- Ability to effectively assist with risk management and complaint management, CAPA root cause analysis & resolution, and maintenance of accurate documentation consistent with applicable quality standards
- Working knowledge of the development, application and measurement of quality performance metrics

BENEFITS

- Paid Vacation
- 401K
- Health Insurance, and more...