§ Provides leadership and direction to Technicians and Analysts by coaching, supervising, and monitoring direct reports through ongoing performance feedback.
§ Prepares and delivers quarterly performance check ins and final performance reviews
§ Coaches employees on development plans and actively support employee development.
§ Supports the implementation and maintenance of quality systems, including data analysis to identify opportunities for quality system improvement.
§ Maintain independence and oversight for product review and approval.
§ Reviews and approves protocols and final reports; escalate deviations from performance standards to their management.
§ Monitors and manages site CAPA’s Non-Conformances and Customer complaints.
§ Writing and reviewing quality system work instructions.
§ Monitors document control, change control and local supplier activities
§ Maintenance and execution of monthly quality metrics reporting.
§ The Lead, Quality Operations is responsible for self-monitoring of their site’s Quality Management System as well as conducting internal audits at sister facilities to ensure the Quality Management System is meeting regulations and standards.
§ Perform quality system audits and related tasks including pre-planning, execution and report writing.
§ Host/support regulatory, Notified Body and Customer inspections, including back office support, ensuring requests are met timely and with the highest level of professionalism.
§ Responsible for conducting and/or supporting audit finding investigations including but not limited to mitigation, corrective action(s) and preventive action(s) where applicable. Collaborate with department managers to develop and implement sustainable remediation action plans.
§ Leads continuous improvement projects for facility.
Valid through: 11/16/2021
$100K — $120K *