Director, Quality Assurance

Job Description

Ensures that all processes are consistent with the laboratory requirements of the various states within the region in addition to Quest Diagnostics SOPs. Oversees, plans, coordinates, and manages quality assessment programs designed to ensure compliance with established standards of laboratory practice, CLIA, state regulations, CAP, and other specialty laboratory accrediting agencies. 

This is an Onsite position. Address: 3601 W 13 Mile Rd, Royal Oak, MI

This role supports Corewell Health. (30 Hospital Laboratories)

Travel: 26-50% (Within state of MI)

Direct Reports: 20 (6 QA and 14 referral specialists)

Internal Grade: 51

Responsibilities:

• Oversees performance of all clinical labs as well as RRLs within the region.
• Provides advice and technical analysis of Quality Assurance (QA) and Quality Control (QC) results with regard to CLIA, CAP, state laboratory standards of practice.
• Examines effectiveness of QA/QC systems through audits of records and departments. Formulates, tracks and manages Corrective Actions.
• Collaborates with the regional medical director and other administrators to implement new Quality Systems into the laboratory organization.
• Develops objectives in cooperation with Lab Operations leadership to maximize test reliability and minimize cost.
• Applies quality management tools and approaches to pre-analytical, analytical, and post-analytical processes within each department, by acting in partnership with Lab Operations leadership teams, subject to the direction of the regional medical director.
• Monitors Quality Assurance goals and standards according to state, federal, and local regulations.
• Leads the quality processes for the West Region, subject to the direction of the regional medical director.
• Ensures for accountability of all Quest Diagnostics sites in the region, including the RRLs, regarding (pre-analytical, analytical and post-analytical) in support of quality processes. Influence will be exerted both directly and indirectly through successful collaboration with the local and regional Laboratory Operations leaders, RRL Managers, and Medical Directors.
• Ensures that all regional sites obtain and retain appropriate licenses and accreditation.
• Teaches, coaches, motivates and inspires direct reports.

Licensing and Accreditation

• Develop and direct an auditing process for all regional sites for all laboratory processes that satisfies the state requirements for all the states in the region, as well as federal and local regulations, College of American Pathologists? (CAP) accreditation requirements, and Quest Diagnostics standards and policies. Ensure, with verification, that corrective action is implemented when non-conformances are found.
• Works with Local RRL and QA Managers, Medical Directors, Human Resources and Regional Vice Presidents to ensure all testing facilities personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations.

Qualifications:

Required Work Experience:

• Ten years successful employment in a Quality Assurance role.
• Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements.
• Experience with managing complex programs with accountability for measured outcomes.
• Must have 5+ years hands-on experience as a medical technologist within the clinical laboratory industry.
• Minimum of five years of management experience.
• Demonstrated success in motivating team members to reach objectives.

Skills:

• Demonstrated ability to lead and drive change.
• Analytic skills, including standard business software tools.
• Strong collaboration and interpersonal communication skills.
• Demonstrated strong writing and composition skills.
• Strong influencing skills.  
• Understands clinical laboratory operations.
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools.
• Able to manage change.
• Organization skills.
• Project management skills.
• People management skills.
• Analytical skills.
• Technical skills.
• Computer skills.
• Able to function in a matrix organization.
• Multi-tasking skills.

EDUCATION
Bachelor’s Degree(Required)
Master’s Degree (Preferred)

50252

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