Quality Engineer / Senior Executive - Quality Assurance

Provide advice and support to the Quality Manager and testing personnel on quality issues.

Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements

Understand the Document Control System (PolicyTech) to ensure SOPs, Trainings and Policies are current versions and assigned appropriately. Notify Department leaders of employee signoffs not completed within deadlines.

Assist in the review of all SOPs, validations, and incident reports to ensure they meet Quality standards and adhere to company guidelines.

Participate in the maintenance of laboratory licensure as required by CLIA and local regulations.

Quality assurance and control of laboratory performance through internal and external audits

Training & Education: Assist with training and education programs, to educate employees and management on quality processes, standards, and results

Project Management: Participate in the planning, initiation, and management of quality improvement projects

Lead and implement various product and process improvement methodologies (e.g., Six Sigma)

Maintain good communication with leadership, team members and customers

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Understand ergonomic relationship between people, equipment and working environment.

Familiarity with operation of laboratory instruments and applicable computer software.

Other duties as assigned

Full time