Quality Control Lead

As the Quality Control Lead at Natec Medical, you will play a pivotal role in upholding our commitment to excellence and regulatory compliance in catheter manufacturing.

Key Responsibilities:

• Lead and mentor a team of quality control technicians and inspectors, providing guidance and support to maintain adherence to quality standards and procedures.
• Develop, implement, and maintain robust quality control procedures and protocols for catheter manufacturing processes, ensuring compliance with FDA regulations, ISO standards, and industry best practices.
• Should ensure that processes and procedures are established, documented, implemented, and maintained to meet regulatory standards and customer requirements.
• Conduct thorough audits and inspections to verify compliance with quality standards, identify areas for improvement, and implement effective corrective and preventive actions (CAPAs) to address deviations.
• Perform Inline audits as a part of regular assessment of processes, procedures, and documentation to verify compliance with ISO 13485 and internal quality requirements.
• Collaborate closely with cross-functional teams to investigate quality-related issues, Customer complaint, conduct root cause analysis, and implement sustainable solutions to enhance product quality and reliability.
• Prepare report and monitor effectiveness of all the controls added or actions taken based on outcome on root cause analysis/Investigation of quality related issues.
• Maintain accurate documentation of quality control activities, including inspection reports, test results, and compliance records, and prepare comprehensive quality metrics and reports for management review.
• Establishes and maintains key performance indicators (KPIs) and metrics to measure the performance of quality processes and systems.
• Analyse data, trends, and feedback to assess the effectiveness of the QMS and identify opportunities for enhancement.

Qualifications:

• Bachelor's degree in engineering, science, or a relate field.
• Minimum of 5 years of experience in quality control/assurance roles within the manufacturing industry, with specific expertise in medical device manufacturing highly desirable.
• Thorough understanding of regulatory requirements (FDA, ISO) and proficiency in quality management systems (QMS).
• Demonstrated leadership experience, with a proven track record of leading teams and driving quality improvement initiatives in a manufacturing environment.
• Strong analytical and problem-solving skills, with the ability to conduct detailed root cause analysis and implement effective CAPAs.
• Proficiency in quality control tools and methodologies (e.g., statistical process control, FMEA, Six Sigma).
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
• Detail-oriented mindset with a steadfast commitment to upholding the highest standards of quality and compliance.