JUNAED SHAFI AHAMED

Handled complaints from international customers inside complaint database (SAP ECC & IBM Lotus notes). Assisted the testing of SAP ECC – 8D / SAP QM IQOS functionality to support European region implementation. Collectively defined the root cause failure codes for SAP ECC – 8D. Assisted in handling complaints using DMAIC, PDSA and 8D. Worked with lean quality tools such as Affinity Diagrams, SIPOC, VSM, SPC, RPN and Fishbone Ishikawa.  Worked with domestic and international cross functional teams

Supported in developing and implementing a QMS by complying with the medical device standard ISO 13485. Collaboratively planned the SOPs (Standard Operational Procedures), associated SFs (Standard forms) and documented them inside XWIKI enterprise management software.  Collaboratively reviewed and audited the SOPs & SFs with cross functional teams and quality committee. Participated and contributed in internal audit and management review sessions. Jointly process mapped applicable quality processes

- Quality Assurance of medical Devices - Quality Management - Immonology and cell biology, - Toxicology - Pharmaco kinetics - Pathology, Hygiene of medical and biological labs

- Quality assurance of medical devices - Microsystems technology - Industrial biotechnology - Biomedical Instrumentation

- Total quality management - Microbiology - Cell biology - Animal biotechnology, - Plant biotechnology - Molecular biology - Genetic engineering - Biofuel technology,