The Quality Assurance Associate participates in the design, creation, implementation and monitoring of programs and methodologies to ensure that Luminex products meet established specifications, design criteria, quality standards and customer requirements.
ESSENTIAL JOB DUTIES
Key Responsibilities of the Job:
- Review and approve records for product release and documents for completeness & accuracy under a production schedule
- Review and update (as authorized) quality system documentation
- Review and approve Design and Development records (studies, reports and data) as assigned
- Review and approve Design History Files
- Track key performance metrics
- Investigates and works with other departments to resolve quality issues related to area assigned
- Participates in internal compliance audits to established Quality System Manual and applicable regulations and standards
- Participates in continuous improvement efforts by completing corrective/preventive actions as assigned
- Participate in performing CAPA effectiveness checks and CAPA follow-up
- Prepares and collects materials for QA meetings and, as assigned, present materials at QA meetings.
- Assist other Quality Assurance personnel in Material Review Board (MRB) activities as needed
- Log, file, maintain and archive various QA reports & records, as assigned
- Support and participate in other QA related activities as required