Quality Control Lead
- Moka
- Negotiable
- Permanent
- Added 29/03/2024
- Closing 10/04/2024
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.