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*Sign on Bonus eligible* Quality Manager-San Diego, CA
Sequenom Laboratories, a wholly-owned subsidiary of Laboratory Corporation of America Holdings (LabCorp), is a CAP accredited and CLIA-certified molecular diagnostics lab located in San Diego, CA. Sequenom is dedicated to the development and commercialization of laboratory-developed tests (LDTs) which improve healthcare by providing revolutionary genomic analysis solutions for the clinical research and molecular diagnostic markets.
Location: 3595 John Hopkins Court San Diego, CA 92121 CAA07
The Quality Manager is responsible for the Quality programs, systems, processes and procedures and that the performance and quality of services conform to established regulatory and accreditation requirements within the assigned laboratory or geographic region. Leads the internal and external audit program and resolution of audit and inspection findings; manages the internal and external proficiency testing program, manages the nonconforming event program and facilities continuous improvement. Oversees compliance with CLIA, CAP, ISO 15189 and other regulatory and accreditation requirements.
This position reports into the Associate Quality Director and/or Quality Director.
PRINCIPAL FUNCTIONAL RESPONSIBILITIES:
Promote a culture of quality
Partner with laboratory leadership to develop quality goals and objectives.
Ensure all laboratories within the assigned area(s) maintain current federal, state and local licensure and accreditations, as applicable.
Provide guidance for laboratories in implementing policies with respect to regulatory and accreditation requirements.
Audit laboratories to identify quality issues, nonconformities and opportunities for improvement.
Formulate responses to accreditation and regulatory citations, nonconforming events and complaints.
Perform root cause investigations and monitor outcomes, corrective action and effectiveness checks.
Facilitate process improvement activities.
Collect summary data for management reports regarding quality indicators, internal and external audit outcomes, and complaints.
Host Quality Management Review Meetings and prepare minutes
Participate in Quality Department improvement projects
Assist in policy and procedure creation for Quality Systems
Provide and ensure training for LabCorp quality policies and procedures.
Maintain and coordinate communications between laboratories in the assigned area(s), provide assistance where indicated on quality related issues.
Supervise Quality Analyst
BA/BS degree in Biology, Chemistry, Medical Technology, or other related science or in the field of Quality Management, 5+ years in Quality Assurance and/or Quality Management preferably in a clinical diagnostic laboratory and 2 years of supervisory experience.
Working knowledge of CLIA/NYS and CAP regulations. ISO 15189 experience a plus
Must possess excellent verbal/written communication and presentation skill.