Quality Manager

Job Summary
Quality Manager will report to the Director of Quality and will be responsible for implementation and management of the Quality Management System, establishment and tracking of Quality KPIs, for developing short and long-range Quality Department plans and budgets.

Essential Job Functions
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 acts 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 ISO 13485 MDSAP and EU MDR 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 corporate 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 FDA and ISO 13485 Registrar.
17. Acts as Management Representative and takes on the responsibilities the representative.
18. Responsible for selection, supervision, and performance management 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.

Requirements
• Three years’ experience required working in an ISO 13485 and FDA- regulated medical device environment.
• Experience in process improvement methods desired.
• Experience reading and understanding regulations, standards, drawings and procedures.
• Supervisory experience strongly preferred.

Knowledge, Skills & Abilities
• Knowledge of FDA cGMP and validation requirements and practices required.
• Working knowledge of the operation of related instrumentation.
• Proficient computer skills with documentation related databases and Microsoft Office (Word and Excel).

Pay Range: $90,000 - $105,000
Pay is dependent on multiple factors, including job related knowledge, skills and experience.

Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression,national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call 716-867-2437.

Salary : $90,000 - $105,000