QA Engineer #65191

Job summary
QA Engineer / Quality Assurance Engineer in the Manufacturing industry
Job seniority: mid-to-senior level
Responsibilities
• Ensure maintenance and continuous improvement of ISO13485 and FDA 21 CFR Part 820 systems • Coordinate with various functions to ensure understanding of the Quality Management System • Plan and coordinate gap analysis exercises and provide advice on bridging the gap • Manage and oversee quality audits and ensure findings and recommendations are implemented • Review and assess the Quality Management System for possible improvements • Arrange for ISO13485, ISO14971, and FDA 21 CFR Part 820 awareness training • Coordinate and plan external audits by customers, ISO certification, and Regulatory bodies • Ensure compliance with ISO13485, ISO14971, FDA 21CFR Part 820, and GDP requirements • Mentor/supervise and ensure timely completion of quality projects • Support plant-wide audit/inspection activities and special projects
Requirements
• Bachelor’s Degree in Quality Management or Electronics Engineering • At least 3 years of working experience in Quality Management Systems and manufacturing • Excellent hands-on knowledge of ISO 13485 and FDA 21 CFR Part 820 • Experience in leading problem-solving and quality improvements • Establishment of control systems required in ISO13485 & FDA registered facilities • Strong communication and interpersonal skills • Preferred FDA inspection experience
Key Skills Needed
• Knowledge of ISO13485 and FDA 21 CFR Part 820 • Communication • Interpersonal skills • Problem-solving