Contract position: A QA Engineer is needed for a leader in electronics, healthcare, and lighting in the Rancho Cordova, CA area. This individual will promote and verify Q&R input and controls are applied to servicing activities including distribution and service activities and that all current and future processes, tools, software and systems are designed validated and released in compliance with applicable Regulations and Standards. No per diem available. No travel is anticipated. Responsibilities for the Quality Assurance Engineer
Requirements for the Quality Assurance Engineer
- Quality Assurance in the processes related to the storage and distribution of materials, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses. The job will include the trend analysis and monitoring of processes, the remediation of field actions, and the development and improvement of Quality systems
- Providing support for regulatory actions and product containment activities (e.g., DPIAs, product holds, recalls, etc.)
- Providing support of business operations 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 discipline
- 1+ years' experience in quality assurance in medical device or other highly regulated industry
- Familiarity with appropriate global medical device regulations, requirements, and standards, such as ISO 13485:2016, 21 CFR Parts 803, 806, and 820. Familiarity with ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169 desired but not required
- ASQ Certification as CQE or DfSS/DMAIC Green (or other recognized Accreditation bodies) is desired
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.