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Excellent computer skills including Microsoft applications.Ability to, internally and externally, discuss and clearly define key technical and process development issues and independently develop course of action / plans. Excellent verbal and written communication skills.Ability to troubleshoot / solve problems independently or as part of a team.Ability to read and interpret prints and tool designs. Knowledge of Good Manufacturing Practices (GMP’s) encompassing plastics extrusion lines, calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods.Experience with Statistical Process Control methods (control charts, CpK’s, etc.).Clear understanding and application of DOE, and PFMEA methodologies.Ability to independently apply analytical skills, complex scientific technical principles and detailed knowledge in solving engineering problems.Lean Six Sigma is required certification is a plus.At least 3 years experience in a manufacturing environment.Bachelor’s degree in a related engineering field such as mechanical, industrial or chemical is required with 3+ years in a Quality Engineering role.
Tekni plex iso#
Assist in audits (internal and external) by third party registrars and / or customers and maintaining the ISO 13485 procedures and work instructions.Working knowledge of process flow maps / diagrams, control plans, PFMEA and measurement system analysis evaluations in support of customer and standard requirements.Responsible for leading validation of extrusion processes, new gauging equipment, new process equipment and products.Development and implementation of quality system documentation and maintenance.Follow Lean Six Sigma (DMAIC) methodology and other Quality tools to determine root cause of problems and implement sound corrective action.Investigate and document customer non-conformances and corrective actions. Respond quickly to customer quality issues including performing investigations, apply root cause analysis and problem solving techniques to address concerns.Act in conjunction with Quality Manager as a technical contact on quality related issues for internal and external customers.Ensures production has the necessary documentation for production runs. Works directly with the quality technicians on product evaluations during the production process, analyzes data from inspection reports and resolves quality problems. Develops, modifies, applies and maintains quality standards and generates protocols and reports. Works with various departments to investigate customer complaints. This includes participation in the development of new products and processes through commercialization, validation, change management and root cause investigations. This position is responsible for supporting quality engineering activities on all aspects of product quality. This job is located at our City of Industry Plant.