US-CA-Temecula: ity Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
* Provide support for high level quality system development and support, including developing new policies and procedures.
* Provide direct support for production and receiving inspection for procedures, record, inspection results and development of these areas.
* Assist in providing support for performing quality system audits (internal and supplier).
* Work with other departments to assist in proper testing of design and process issues, for technology, test design, statistical analysis and review for conformance to protocols.
* Performs product and process validations.
* Root cause analysis of customer complaints & internal nonconformance.
* Provide Training to ensure proper implementation and use of quality tools and procedures.
* BS degree in life sciences or work equivalent
* Minimum 2 years experience in a Class II or Class III drug manufacturing, medical device, or biologics industry in Quality Assurance or Quality Engineering position.
* Certified Quality Auditor and/or Certified Quality Engineer preferred.
* Strong statistical knowledge needed. Must be able to solve complex problems related to engineering issues, quality system issues and production or supplier related concerns.
* Strong understanding of QSR's, ISO9001:2000 or ISO 13485:2003,MDD.
* Able to work well in a team environment.
* Ability to work and communicate effectively with all areas and levels of the organization.
* Excellent analytical skills.
* Excellent written communication skills.
* Proficient in software applications; Word, Excel.
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI