Role Description
1. Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
2. Demonstrates knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
3. Responsible for implementation and management of the Quality Management System
4. Responsible for the establishment and tracking of Quality KPIs.
5. Develop short and long-range Quality Department plans and budgets.
6. Develop and implement standards, methods, and procedures for process validations, equipment calibration and contamination control.
7. Implement and ensure execution of all inspection activities.
8. Assure that all work performed conforms to 21 CFR 820, EU MDR 2017/245, Health Canada SOR/98-282, Japan MHLW 169, Australia Therapeutic Goods Regulation 2002, Brazil RDC ANVISA, UKCA, and ISO 13485 standards and is conducted in accordance with cGMP regulations on the production floor.
9. Write, revise and review Standard Operating Procedures (SOPs), validation protocols and test plans and protocols that are pertinent to company product quality.
10. Implement performance standards for testing of equipment and scheduling of calibrations.
11. Oversee the resolution of customers’ technical issues and complaints.
12. Schedule and conduct Management Reviews.
13. Identify and implement process improvements.
14. Address and implement corrective and preventive actions
15. Manage the scheduling and execution of internal and external audits.
16. Act as the primary company interface with the Notified Body and other Regualtory Agencieis, as applicable (Management Representative).
17. Ensure compliance of customer and regulatory requirements for product introductions and changes throughout the product’s lifecycle.
18. Responsible for selection, supervision, and performance management/coaching of department employees.
19. Participate in staff management training and effectively manage employees in compliance with federal and state employment laws and regulations.
20. Interview, hire, and train new department employees.
21. Conduct timely performance reviews, establish clear goals, and support learning opportunities for job skills and career growth.
22. Abides by all safety and security rules set forth by the company and regulatory agencies
23. Other dutie may be assigned.
Wanted/Desired experience/skills/charactersitics:
24. Three years’ experience required working in an ISO 13485 regulated medical device environment.
25. Experience in process improvement methods desired.
26. Experience reading and understanding regulations, standards, drawings and procedures.
27. Supervisory experience strongly preferred.
28. Knowledge of cGMP and validation requirements and practices required.
29. Working knowledge of the operation of related instrumentation.
30. Proficient computer skills with documentation related databases and Microsoft Office (Word and Excel).
Education level required/desired
31. Bachelor’s degree in Business, Science, or Engineering required. Master’s degree preferred.
32. CQM Certification desired.