Job role: Quality Assurance Engineer
Location: Pleasanton, CA
Duration: Contract
Responsibility:
4 to 6 years in Medical devices Quality with Manufacturing background.
Experience in reviewing validation protocols/reports (IQ, OQ, PQ), Test Method validation & Inspection Method validation protocols/ reports
Accountable for decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action), Internal Customer Signals (ICS), and Product Requests for Analysis (RFA).
Collaborate with key stakeholders to develop and maintain procedures and forms for the CAPA, product RFA, and ICS systems.
Lead CAPA, ICS, and RFA detailed data analysis, trending, and reporting. Publish weekly, monthly, and quarterly metrics.
Track manufacturing related complaints in alignment with Abbott goals.
Support Global CAPA team with training, CAPA oversight, and CAPA deliverables.
Participates in or leads in the completion of risk assessments (PFMEA)
ASQ CQT, CQE, CQA certification preferred