Contract position: A Validation Engineer is needed for a leader in electronics, healthcare, and lighting in the San Diego, CA area. This position will guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing. No per diem available. 20% travel required. Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Maintain, Validate and Release Test Systems in Production Environment. Guide and participate in bug testing, identification, and problem solving.
- Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within manufacturing environment.
- Bachelor's degree in Engineering or Technology are preferred, but degrees in Quality, Regulatory and Software Engineering are accepted as well.
- At least 5 years of experience in software validation of R&D. Experience with HP Quality Center, SAP, Trackwise, Enovia, Windchill, DOORS, etc.
- Experience and Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous work with such bodies during regulatory assessments or inspections.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.