Compliance Engineer

Immediate 6+ month contract opportunity possible temp to perm opportunity for a Regulatory Compliance Specialist with expertise in Corrective/Preventative Action. The right candidate will have a wide array of responsibilities to include maintenance of the CPA system and database to internal and external compliance audits, such as Corporate, ISO and or FDA. This is a great assignment in very convenient location of the San Jose area!

RESPONSIBILITIES

- Maintenance of the Corrective/Preventative Action System and database
- Assess CAR requests, which includes issuing CARs and recommending appropriate ISO element. Evaluate responses and conduct verification audits and report findings to closure.
- Assist in internal audits by assessing conformance to regulations and making recommendations on appropriate action
- Assist in external compliance audits, such as Corporate, ISO and or FDA compliance audits
- Participate in the Material Review Board (MRB) process, and provide recommendations and assistance from a compliance perspective
- Assist with data analysis for Product Inquiry Reports (PIRs) and recalls as needed
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements
- Establishes and promotes a work environment that supports the COmpany's Quality Policy and Quality Systems

REQUIREMENTS

- Degree highly preferred
- Previous experience with Corrective/Preventative Action
- Experience with CAR requests and making recommendations on appropriate actions
- Medical Device is a major plus

BENEFITS