Director, Quality Assurance
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Job Location:
Royal Oak, MI - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Department:
Job Summary
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 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 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 Diagnosticsstandards and with verification that corrective action is implemented when non-conformances are found.
- Works with Local RRL and QAManagers 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
Bachelors Degree(Required)
Masters Degree (Preferred)
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
Quest Diagnostics (NYSE: DGX) empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care mana ... View more
