Quality Assurance Manager

Quality Assurance ManagerJOB ***** The Quality Assurance Manager will provide site leadership and direction to meet customer quality requirements. This position will also create, monitor, and improve quality programs while reducing quality costs and maintaining compliance within FDA and ISO regulations. This is accomplished by utilizing Tecomet's standards of Safety, Quality, Schedule and Customer InnovationESSENTIAL **Promote and develop plans with Tecomet's customers to certify Tecomet as a preferred supplier.Develop and maintain customer relationships.Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs.Optimize manufacturing process run time by identifying and eliminating production failures.Coach and provide training for Quality Engineers, Six Sigma Green Belts, and Quality Inspectors.Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans.Determine if a potential supplier has the basic systems and machine capabilities in place prior to placing an order with that supplier.Develop and administer systems that facilitate the certification of suppliers, subsequently reducing and/or eliminating Tecomet's receiving inspection time and cost.Follow-up on all internal and external corrective action responses .Internal & external audits and supplier approvals.Oversee special processes validations.Oversee gage control.Device pre-sterile packaging and sterilization requirements.Project a positive and professional image of the company and of management to employees at all levels .Knowledge *Receiving, in-process, and final inspection techniquesDeveloping inspection criteriaQuality audit processes and maintenance of master device history recordsCMM Programming and inspection techniquesGage and CalibrationStrong organizational skillsStrong people and leadership skillsExcellent verbal and written communication and listening skillsProblem solving and evaluationProcess improvementsComputer operationCore technical *Lean principlesStandard measuring devicesGeometric Dimension &Tolerance GD&TProject managementQuality audit processesCore education and ** Bachelor of Science Degree or related field.Six or more years of experience.Or equivalent combination of education an/or experience.*****ASQ, CQE, CQA, and/or CQM Knowledge of ISO/FDA Requirements

Created: 2025-02-20