.Company Description**Job Description**:**Production Quality Engineer**Job Description SummaryThe incumbent is responsible and accountable for establishing and coordinating Quality Control Plan activities for materials, products, equipment, processes and software.Lead in investigating manufacturing product quality issues, non-conformances, audit observations and customer complaints. Develop problem-solving methodologies from production processes based on engineering and statistical principles.You will lead the Risk Analysis/ PFMEA to identify needs for validation of manufacturing equipment/ process / software and support systems to meet product requirements, regulations, quality and company policies.Job Responsibilities- Responsible for developing, implementing and maintaining the Risk Analysis / FMEA and Validation Master Plan for the Plant & supporting Quality Engineering activities including process monitoring, continuous improvements, metric reporting, data analysis, change control & control plans- Coordinates, supervises groups of Quality Assurance personnel on an ongoing validation activity for any projects in production- Responsible for providing support, training and assistance to production and quality personnels- Continuously evaluate information related to the overall performance of manufacturing process / equipment / software and any relevant support systems in addition to field complaints to activate re-validation activities when required- Create, revise or update validation procedures and policies as required. Prepare Change Notification documentation as required for procedures or processes as a result of validation requirements- Participate in Management Reviews and Executive Steering Committee to report on Quality status- Perform internal QA Audits. Assist/support in external customer and regulatory audits as required- Leads cross functional teams for quality initiatives project for continuous improvements as per Quality tools such as Design of Experiments, Statistical/ Data Analysis, and MSA / CorrelationJob Requirements- Bachelor's Degree or equivalent in related Engineering field- Minimum 5 years relevant working experience in an assembly operations/engineering environment.- Good knowledge of PFMEA, process/software validation and various statistical control methods- Strong background in QMS 9001- Strong analytical and problem-solving skills- Knowledgeable root cause investigation tools such as 5 Whys, fish bone diagram and Is/Is Not analysis- Working knowledge of statistical tools - Cpk, SPC, MSA- Substantial understanding and knowledge of calibration, measurement techniques and metrological concepts.- Computer literacy in MS Office modules and Google Workspace deseable- Must have good language proficiency in English- Added advantage in process analysis, problem solving skills, and improvement using process flow and/ or Lean Manufacturing method
