Must Have:

Sr. Quality Engineer with 15 years of experience With CAPA is MUST.

Job Description: -

We are looking Sr. Quality Engineer with 15 years of experience along with the following skill set-

• Risk analysis, risk assessments, PFMEA, DFMEA to corporate quality systems.
• Hands on experience in leading investigations, Design controls and DHFs with the team to identify root cause and the development and implementation of corrective action plans.
• Well versed with root cause analysis product failure analysis, DHF/FMEA assessment, Risk Management (ISO 14971), process improvement.
• Well versed and high knowledge on FDA, cGMP, 21 CFR Part 11, Part 210, 211 and 820, ICH Q7 and Q10), ISO 13485 and 9001. Expertise in product failure analysis, DHF/FMEA assessment, Risk Management (ISO 14971), process improvement.
• Experience in leading customer complaints/ Post market surveillance reporting (MDRs, MDVs, MDPRs, etc.). Experienced in using Minitab, Gauge R&R, AutoCAD, and applicable knowledge on GMP, FDA, ISO, SOP, and Quality Standard regulations.
• Quality engineering activities for products, including process validation, maintenance of DMR and risk management files, complaint risk analysis and CAPA/SCAR/Deviation investigations- CAPA is MUST.
• Review & revision of CAPA systems adherence to ISO 13485 & ISO 14971, cGMP, 21 CFR 820, 210, 211, 803, 806, MDD, EU requirements.