Asst Quality Assurance Manager

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.