Description
JOB PURPOSE:To work under the direction of the Quality Manager and Senior Management to maintain the Quality Management System (QMS) for compliance with Medical Device standards and regulations.
Establish and manage quality improvement projects in accordance with company goals and objectives
Work with product development teams and other parts of the organization to ensure appropriate Quality Engineering is implemented within development projects.
Participate in project teams implementing corporate quality initiatives
MAIN DUTIES:
1. Implement and maintaining the company's Quality Management System
2. Managing and implementation of quality metrics
3. Ensuring compliance with national and international standards and legislation
4. Managing and maintaining controls and documentation relating to QMS
5. Maintaining and organizing the company's internal quality audit program and managing corrective and preventive action plans
6. Managing of company purchasing controls and organizing and conducting supplier audit program
7. Participation in risk management activities and ensuring conformity of the risk management process.
8. Participating in audits by internal customers and third parties certification and regulatory bodies
9. Managing of project records into Design History Files and Technical Construction Files etc.
10. Manage equipment calibration and preventive maintenance program.
SPECIFIC KNOWLEDGE / TECHNICAL SKILLS REQUIRED:
1. At least 5 years' experience of quality management within a medical device development context involving hardware, software and biological systems
2. Thorough working knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 and the In Vitro Diagnostics Directive (IVDD)
3. Knowledge of standards IEC 62304, IEC 62366 and IEC and IEC
4. Thorough working knowledge of Good Laboratory Practice and ISO 17025
5. Knowledge and experience of process excellence activities such as LEAN 6 Sigma.
6. Excellent communication and interpersonal skills and good leadership skills
7. Proven strong problem solving ability and root cause analysis skills
8. Meticulous approach with close attention to detail