Key Responsibilities: Quality Assurance Strategy and Implementation: Develop, implement, and manage the quality assurance processes for plastic injection molding operations, ensuring compliance with ISO 9001, ISO/TS 16949 (automotive), ISO 13485 (medical devices), and other relevant standards.Create quality control plans that adhere to automotive and medical product requirements, ensuring defect-free production.Establish and maintain quality standards, policies, and procedures specific to the manufacturing of automotive and medical plastic components.Regulatory Compliance: Ensure compliance with automotive industry standards (IATF 16949), medical device regulations (FDA, ISO 13485), and other applicable regulatory standards.Lead efforts to maintain certifications and pass industry audits (e.g., FDA audits for medical devices, automotive supplier audits).Stay up-to-date with industry regulations, ensuring that processes meet current compliance standards for both automotive and medical products.Supplier and Customer Quality Management: Collaborate with suppliers to ensure that raw materials and components meet specified quality standards.Address and resolve quality-related issues with suppliers to minimize defects in the injection molding process.Liaise with customers to ensure that products meet their requirements. Team Management: Lead, mentor, and manage a team of QA engineers, inspectors, and technicians to ensure consistent quality standards throughout the production process.Allocate resources effectively, assigning team members to critical quality control areas to meet production and regulatory deadlines.Provide training to the QA team and other departments on automotive and medical industry-specific quality standards and procedures.Product Testing and Inspection: Oversee the testing of plastic injection-molded components to ensure they meet automotive and medical specifications, including mechanical, visual, and dimensional inspections.Implement statistical process control (SPC) and other testing methodologies to monitor product quality during production.Ensure that all automotive products undergo appropriate functional and durability testing, and medical products meet sterilization, biocompatibility, and other safety requirements.Defect and Non-Conformance Management: Establish processes to identify, document, and address defects and non-conformances in both automotive and medical product lines.Lead root cause analysis investigations using methodologies such as 5-Why, Fishbone Diagram, and Failure Mode and Effects Analysis (FMEA).Implement corrective actions to resolve quality issues and prevent recurrence in the injection molding process.Process Improvement: Continuously analyze production processes to identify areas for quality improvement and efficiency gains.Work closely with the engineering and production teams to implement lean manufacturing and Six Sigma practices aimed at reducing waste and defects in the plastic injection molding process.Drive initiatives for the introduction of automated quality inspection tools and technologies to improve the accuracy and speed of defect detection.Documentation and Reporting: Ensure the creation and maintenance of comprehensive quality documentation, including inspection reports, test results, Control Plans, PFMEA (Process Failure Modes and Effects Analysis), and validation reports.Provide regular quality performance reports to senior management and customers, tracking KPIs such as First Pass Yield (FPY), Cost of Poor Quality (COPQ), and customer complaints.Ensure accurate and detailed records for traceability of medical products, including device history records and batch records.Audit and Certification Management: Prepare for and lead internal and external audits, including ISO, IATF, FDA, and customer-specific audits.Ensure that all quality systems and procedures are audit-ready, identifying and addressing any potential non-conformances before they escalate.Customer Interaction and Feedback: Address customer complaints and feedback promptly, working with cross-functional teams to resolve issues and improve product quality.Lead customer quality meetings, presenting data and solutions related to quality performance, customer satisfaction, and continuous improvement initiatives. Qualifications and Skills: Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related field. A Master's degree or certifications such as Certified Quality Engineer (CQE) or Six Sigma Black Belt is preferred.7+ years of experience in quality assurance or quality control, with at least 3+ years in a managerial or supervisory role within the plastic injection molding industry.Experience working with automotive and medical device manufacturing standards and regulatory requirements.Extensive experience in ISO 9001, ISO/TS 16949, ISO 13485, FDA compliance, and PPAP processes.Proficiency with quality management tools such as SPC, FMEA, Root Cause Analysis, and CAPA (Corrective and Preventive Actions).Familiarity with CAD/CAM software, CMM (Coordinate Measuring Machines), and 3D inspection technologies.Extensive knowledge of IATF 16949 for automotive products and FDA/ISO 13485 for medical devices.Strong understanding of validation and qualification processes required for medical device production.
