Nissha Medical Technologies is looking for a Quality Specialist in Buffalo, NY. The position is responsible for ensuring all Quality Management System Documentation functions are completed and compliant with internal procedure, ISO 13485 standards, and FDA Regulations.
Essential Job functions:
- Conduct investigations and initiate identified Corrective/Preventive actions (CAPAs) resulting from Non-Conformance and/or complaint investigations. Responsible for contacting the appropriate parties to obtain any information needed to aid in investigation.
- Ensure all required notifications occur within established regulatory requirements and timely closure of all complaints/events and associated documentation.
- Knowledgeable of applicable regulations and internal policies/procedures ensuring operational compliance.
- Conduct training as required.
- Participate in External Audits/Inspections as needed and conduct internal audits as assigned.
- Interface on a continual basis concerning Quality System performance and issues with Management and Staff.
- Complete other department related functions that contribute to the effectiveness of the Quality Management System.
- B.S. Degree.
- Minimum 3 years Quality Assurance experience within FDA/ISO regulated industry.
- Understanding of GMP
- Computer Proficient (Microsoft Office Suite required).
- Strong written and oral communication skills
- Experience with non-conforming Materials/Events & Material Review Boards
- Experience in advanced problem-solving including root cause analysis, and Corrective/Preventive Action Programs to include the verification of effectiveness
- Sound understanding of quality concepts, compliance requirements and tools including 21 CFR Part 820 and/or ISO 13485
Graphic Controls, a Nissha company, is an Equal Opportunity Employer; and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Graphic Controls will provide reasonable accommodations for qualified individuals with disabilities.