Job Openings >> Quality Specialist
Quality Specialist
Summary
Title:Quality Specialist
ID:1940
Department:Quality
Location:Buffalo, NY
Description

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.


Requirements

  • B.S. Degree.
  • Minimum 3 years Quality Assurance experience within FDA/ISO regulated industry.
  • Understanding of GMP
  • Computer Proficient (Microsoft Office Suite required).
Knowledge Skills and Abilities
  • 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.

This opening is closed and is no longer accepting applications
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CONTACT US
Nissha Medical Technologies
400 Exchange Street
Buffalo, NY 14204
Nissha Medical Technologies is the medical devices business unit and wholly owned subsidiary of Nissha Co. Ltd., a Japanese publicly held company based in Kyoto, Japan (TSE:7915).
Copyright 2020 Nissha Medical Technologies. All rights Reserved
The OEM trademarks identified herein are the trademarks of the respective OEMs, and not Nissha Medical Technologies. Nissha Medical Technologies disclaims any affiliation, connection or association between it's products and those of the respective OEMs.