Requirements
Bachelor’s degree in Science, Chemistry, Pharmacy, Engineering, or a relevant scientific discipline.Minimum 8 years of experience in Quality Control within the medical devices, medical supplies, or pharmaceutical manufacturing industry.Minimum 3 years of experience in a managerial or supervisory position.Previous experience in medical-device manufacturing is highly preferred.Strong knowledge of ISO 13485, GMP, GLP, CAPA, OOS, deviations, nonconformities, root-cause analysis, and risk management.Strong experience in laboratory management, inspection activities, quality documentation, and audit preparation.Good leadership, team-management, analytical, and problem-solving skills.Excellent communication and cross-functional coordination skills.Good command of English.Proficiency in Microsoft Office applications.Ability to work under pressure, manage priorities, and make effective quality-related decisions.
Description
Manage and supervise all Quality Control activities, laboratory operations, and QC personnel.Ensure that raw materials, packaging materials, in-process products, and finished products comply with approved specifications and quality requirements.Develop, review, and implement QC procedures, specifications, testing methods, inspection plans, and Standard Operating Procedures (SOPs).Review laboratory test results and inspection reports and ensure the accuracy and reliability of QC records.Supervise physical, chemical, and microbiological testing activities, as applicable.Ensure the proper calibration, qualification, verification, and maintenance of laboratory equipment.Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results.Participate in investigations related to deviations, nonconformities, customer complaints, and product-quality issues.Conduct root-cause analysis and develop and follow up Corrective and Preventive Actions (CAPA).Ensure compliance with ISO 13485, GMP, GLP, applicable regulatory requirements, and the company’s Quality Management System.Participate in internal audits, supplier audits, customer audits, and regulatory inspections.Monitor quality trends, rejection rates, recurring defects, and departmental KPIs.Coordinate with Quality Assurance, Production, Engineering, Warehouse, Purchasing, and other departments to resolve quality-related issues.Lead, train, coach, and evaluate the Quality Control team.Prepare periodic QC reports and recommend continuous-improvement initiatives.