Contract position: A QA Engineer is needed for a leader in electronics, healthcare, and lighting in the Rancho Cordova, CA area. This position will promote and verify Q&R input and controls are applied to all operations activities including manufacturing, quality controls, warehousing, distribution and service activities. No per diem available. No travel is anticipated. 1st shift: 8:00 AM - 5:00 PM. Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Quality Assurance in the processes related to the manufacturing (internal and external), quality control, storage and distribution of materials, components, sub-assemblies, and completed products and their supply chain.
- Introduction/validation of new/changed manufacturing processes and their associated Q systems, the trend analysis and monitoring of manufacturing processes and their environment.
- Provide support (Change Controls, CAPA/SCAR, NCR) of operations for NPI/Sustaining projects ensuring on time completion of project deliverables, correcting issues delaying completion and reporting on QMS status of projects.
- Bachelor's degree in a Technical, Science, or Engineering field with at least 5 years of experience in quality assurance/operations in a medical device industry.
- Expert understanding of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC).
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.