Role: Quality Assurance Engineer
Location: Pleasanton, CA-Onsite
Contract on C2C/W2
• 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
Thanks & Regards,
Arijit Gain
US IT Recruiter
MSR Technology Group LLC d/b/a i3infotek Inc.
Phone: +1 (732)-929-7092
Email: arijit.g@msrtechnologies.com/arijit.g@i3infotek.com
LinkedIn:linkedin.com/in/arijit-gain-08a12g1999
www.msrcosmosgroup.com