Quality Assurance Specialist to provides support to complaint product return, investigation, and resolutions and conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes.
Responsibilities:
- Completes compliant documentation and provides solutions to local problems of low scope and complexity.
- Supports project work and acts as community member.
- Quality System Compliance: Maintains awareness of industry regulatory standards.
- Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to the department manager.
- Applies basic Risk Management principles to work.
- Review complaints.
- Generate exception/CAPA documentation such as non- conformance reports and investigation reports required at the site for routine and non-routine issues.
- Investigate all aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective/preventive actions.
- Utilize data and quality policies as necessary to support investigations.
- Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities.
- Work with other affiliates and regional groups as needed to recommend/document appropriate corrections, corrective/preventive actions based on facts obtained during base CAPA investigations.
- Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
Requirements
- Bachelor s Degree in Engineering or Science with major in Electrical, Mechanical, Computer Science, Chemical, or any field of life science.
- Minimum of 3 years of relevant experience in a regulated environment (preferable FDA regulated industry).
- ISO 13485, FDA 21 CFR 820, and Lean Six Sigma Green Belt certification highly desirable.
- ASQ Certifications are a plus
- Bilingual (English & Spanish)
- MS Programs
- Training Compliance
Bachelor s Degree in Engineering or Science with major in Electrical, Mechanical, Computer Science, Chemical, or any field of life science. Minimum of 3 years of relevant experience in a regulated environment (preferable FDA regulated industry). ISO 13485, FDA 21 CFR 820, and Lean Six Sigma Green Belt certification highly desirable. ASQ Certifications are a plus Bilingual (English & Spanish) MS Programs Training Compliance