RecruitPod Global · 20 hours ago
Quality Assurance Manager
Houston, TX
Full-time
Onsite
Senior Level
5+ years expRecruitPod Global is seeking a highly skilled and detail-oriented QA/QC Manager to oversee quality assurance and quality control processes within a medical testing laboratory. The ideal candidate will lead the development, implementation, and continuous improvement of quality systems to uphold the highest standards of accuracy, safety, and compliance in a dynamic healthcare environment.
Staffing & Recruiting
Hiring Manager
Abdul R.
Responsibilities
Develop and maintain comprehensive quality management systems aligned with CLIA/CAP regulations
Identify training needs and ensure everyone performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed
Maintain and establish a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results
Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications
Evaluate the competency of all testing personnel and ensure the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to
Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing
Monitoring the recording and reporting of test results
Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
Direct observation of performance of instrument maintenance and function checks
Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples
Assessment of problem-solving skills
Lead internal and external quality audits to verify compliance with regulatory requirements and industry best practices
Oversee quality inspection procedures across all laboratory processes to identify areas for improvement and ensure adherence to specifications
Manage documentation control, including validation protocols, calibration records, and audit reports to support regulatory submissions
Coordinate with laboratory management and staff to implement robust quality control measures that ensure the accuracy and reliability of test results
Conduct root cause analysis for non-conformances and implement corrective and preventive actions (CLIA) to mitigate risks
Evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation
Provide leadership in training staff on quality systems, regulatory updates, and best practices in laboratory operations
Drive continuous improvement initiatives by analyzing data trends and integrating new methodologies into existing quality frameworks
Perform various additional duties, as required and necessary for effective business operations
Qualification
Required
Bachelor's degree in science or related subject, or Medical Laboratory Scientist (MLS) or equivalent with the American Society of Clinical Pathology or acceptable equivalent
5-7 years in quality control and quality assurance is required
Previous laboratory management experience is required
Clinical laboratory experience is required
Experience working and communicating with all levels within an organization
Experience in document control establishment and maintenance
Highly proficient in Microsoft Excel
Must adhere to all HIPPA regulations, OSHA and CLIA rules and regulations for laboratories including use of PPE
The ability to multitask and manage daily changes in workflow with flexibility and good judgement
The ability to work in a changing team environment, as well as independently, with efficiency, accuracy, and professionalism
The ability to be meticulous, with high attention to detail
Must be flexible and willing to work in areas and on problems that may not normally be part of the position but required for the efficient operation of the business
Proven experience in quality assurance and quality control within a medical testing laboratory or related healthcare environment
Strong understanding of CLIA/CAP standards for medical testing
Demonstrated ability to conduct thorough quality audits and manage complex projects effectively
Excellent analysis skills with a focus on problem-solving and process optimization
Exceptional organizational skills with attention to detail in documentation and compliance activities
Effective communication skills to collaborate with cross-functional teams and regulatory bodies
Preferred
Quality Control/Quality Assurance certifications preferred (ASQ, CMQ, etc.)
Knowledge of manufacturing processes related to medical testing equipment or consumables is advantageous
Company
RecruitPod Global
RecruitPod Global offers personalized hiring solutions to meet end-to-end consulting services, empowering businesses to achieve their strategic goals and optimize their operations.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase