Quality Assurance Engineer

Quality Assurance

Location: San Diego, CA Onsite

Contract: 6-12+ months

Client: HCL America

Visa: OPT, GC

**Updated LinkedIn ID Required

Required Skills

• Minimum of 5-8 years of experience required.
• Audits independent set of eyes to review various records and compare according to procedural requirements for both infusion and dispensing (e.g. TMVs)
• Access to SAP and fluent in looking up materials, BOMs, etc.
• End to End knowledge of Product Lifecycle for an EMI product from Design Controls through Design Transfer, inclusive of Sustaining Activities in Production. For example, I have a project which will be to observe current production processes and create production specs (remediation) and then a traceability matrix that ties design outputs to final testing in manufacturing. Material Masters, Inspection Plans, Final MBIs and TIs may need to be updated.
• Trace EDOs and remediate downstream production activities to those EDOs (e.g. update inspection plans, compare testing and user manual, evaluate final acceptance and controls)
• Knowledge of environmental monitoring in warehouse
• Familiarity with RoHS requirements and creation of Environmental Files which will include working with suppliers and procurement
• Exceptional English technical writing skills

Nice to have:

• Prior knowledge of the MMS organization (knowing who to reach out to with a question)
• Knowledge of ESD directives, regulations and best practices
• Can own CAPAs and perform investigations and corrective actions, has previously owned CAPAs and can assist CAPA owners
• Knowledge of Global Hold process at MMS
• PowerBi and ability to create dynamic reports or report on metrics