Quality Manager

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.