Asst Quality Assurance Manager

Job Description

Job Summary Reporting to the QA Manager assures consistent quality of production by developing and enforcing good, automated manufacturing practice (GAMP) systems; validating processes; providing documentation; managing/coaching staff and third parties; Driving for supply chain continuous improvements. Essential Duties and Responsibilities QA Execution Manages the QA and QC team consisting of Quality engineers, Quality inspectors and various third parties. Conducts detailed monitoring, analysis and reporting of factory quality performance. Identifies, prepares and implements action plans related to productivity, process, quality, and customer-service standards. Coordinates vendor responses to corrective action plans and on-site monitoring of their effective implementation. Works with the US-based engineering and QA teams to develop quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; Validates quality processes by measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods. Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations. Any other duties assigned from time-to-time by line Manger. Knowledge, Skills and Abilities Knowledge of continual process improvement from a lean manufacturing perspective. Strong analytical skills and ability to conduct statistical analysis related to product failures. Must be able to read and interpret engineering prints and drawings Excellent communication skills both verbal and written. Excellent attention to detail. Ability to negotiate compromise solutions. Education and/or Experience Bachelors Degree from a four-year college or university; or 5-10 years related experience and/or training/ or equivalent combination of education and experience preferred. Good communication Skills in English and Hindi Project Management in a Manufacturing/Engineered Product environment. Six Sigma Green or Black Belt preferred.