Clinical Quality Engineer II

Position Summary

The Clinical Quality Engineer II plays an integral role on the Quality team and supports the company's compliance activities with CLIA, CAP, ISO 15189, NYSDOH, and applicable state requirements. This individual also supports the company’s quality activities that comply with the FDA’s Quality System Regulation and ISO 13485. The Clinical Quality Engineer II works closely with a variety of departments to support quality activities and identify opportunities for continual improvement.

Essential Duties And Responsibilities

• Support quality activities as it relates to the clinical laboratory, including activities related to pre-analytical, analytical and post analytical phases
• Support issues arising in the clinical laboratory and work closely with Clinical Operations to determine root cause and potential preventative/corrective actions
• Aids in creating good laboratory processes and assists with issue resolution
• Assists with verification and validation testing and troubleshooting activities
• Maintain quality metrics required for management review
• Provides guidance on Change Control activities
• Cover proficiency testing program
• Review and improve standard operating procedures / other QMS documentation as needed
• Ensures required LDT requirements are completed prior to product transfers and product launches
• Coordinate proficiency testing program activities
• Represent Quality at cross-functional meetings
• Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable
• Ensure that all policies, procedures, and records are reviewed and approved
• Execute special projects as assigned

Qualifications

• M.S. degree or higher in a relevant field with 0–2 years of related experience or a B.S. degree in Chemistry, Biology, Engineering, or a related scientific discipline with 2+ years of quality experience in the Life Sciences industry
• Experience in compliance with quality standards in a regulated Molecular laboratory (e.g. CLIA, CAP, NYSDOH, etc.)
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
• Ability to constructively challenge concerns and engage in transparent conversations
• Ability to work effectively in a team environment and build strong working relationships
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
• Prior proven attention to detail and accuracy
• Effective organizational skills
• High degree of initiative and self-motivation
• Drive for results and continual improvement – Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement