Quality Assurance Quality Engineer
We are looking for a quality engineer to monitor and improve the quality of our operational processes and outputs. The quality engineer's responsibilities include designing quality standards, inspecting materials, equipment, processes, and products, developing quality control systems, and determining corrective actions. You will also work with managers and supervisors to implement quality measures.
RESPONSIBILITIES
Planning, coordination and implementation of the quality assurance program. Formulation of the quality control processes.
- Communication to Management of Quality Issues including, but not limited to, complaints, site audits (FDA, EPA, DEA), and off specifications, and the performance of the quality system.
- Back up for ISO.
- Perform the role of the Independent Quality Unit in the monitoring and control of quality processes including, but not limited to change control, deviation handling, raw material and product release, and validation.
- Implementation, adaptation, maintenance, improvement, and training of the processes that constitute the Quality System. Work closely with production staff.
- Provide QA Approval and Oversight for manufacturing sites.
- Technical support for manufacturing shop floor.
- Provide quality approvals on product change and raw material change requests, GMP compliance issues as well as others.
- Perform, or coordinate, quality audits of suppliers and 3rd party manufacturers.
- Lead root cause analysis on complaints and product and process deviations.
- Special projects and additional duties as required by direct management.
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