Job Responsibilities
Quality Management System : Lead and manage QMS in compliance with ISO 13485, IATF 16949, ISO 9001, and ISO 14001 standards.
Quality Operations : Oversee IQC, IPQC, OQC, customer quality, and supplier quality functions.
Customer Complaints : Manage CAPA, NCR, SCAR, and root cause analysis activities.
Audits : Lead internal, external, and customer audits.
Regulatory Compliance : Ensure adherence to medical device manufacturing requirements and automotive quality standards.
Process Validation : Support IQ/OQ/PQ, SPC, FMEA, MSA, APQP, PPAP, and control plan activities.
Quality KPIs : Monitor yield, FPY, DPPM, scrap, and customer complaint metrics.
Continuous Improvement : Drive initiatives using Lean Manufacturing and Six Sigma methodologies.
Team Leadership : Lead and develop the Quality team to achieve departmental objectives.
Job Requirements
Education : Bachelor’s Degree in Engineering, Quality, Biomedical, Manufacturing...