Quality Assurance Manager Job at Acutis Diagnostics Inc
The Quality Assurance Manager oversees all quality assurance activities in the Hicksville, NY and Monmouth Junction, NJ laboratories? they will provide leadership by communicating and achieving department objective; Hicksville will be the primary work location although travel to New Jersey will be required. This role will report directly to the Director of Quality Assurance.
- Communicate and maintain a quality management program to meet regulatory requirements of all standards and identify quality processes set forth by state, federal, licensing and accreditation agencies including CAP, CLIA, NYSDOH, FDA Part 820.
- Manage the daily activities and monitor the daily workflow in the QA department.
- Collaborate with the upper management team to set quality benchmarks.
- Follow up on all quality assurance/quality management issues.
- Supervise staff: hire, train, discipline, and supervise staff in collaboration with the leadership; evaluates performance and ensures appraisals are completed on a timely basis.
- Maintain laboratory documentation to ensure traceability.
- Brainstorm ideas to increase productivity and performance of direct reports.
- Consult with lab supervisors and managers in developing improvement initiatives.
- Collect and store documents supporting proper validation of the reagents, supplies and equipment.
- Conduct investigations of the test failures and procedure deviations.
- Promote the continuing Quality Improvement efforts of the laboratory.
- Facilitate successful completion of proficiency testing events and corrective actions.
- Support Quality Assurance activities related to the development, implementation and maintenance of document control and change control.
- Foster a culture of compliance and quality.
Shift Information:
Monday ? Friday, 9AM ? 5PM, shifts extend until work is completed
Occasional weekends
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