- Experience in a Clinical Laboratory Improvement Amendments (CLIA) quality role including quality team management. Strong understanding of the principles, practices, and techniques of the various pre-analytical, analytical, and post-analytical areas of the clinical laboratory preferred.
- Experience managing quality assurance and quality improvement within the overall Quality Management System (QMS) of a clinical laboratory including the development, implementation, monitoring, and communication of all laboratory quality processes and procedures preferred.
- Expertise for compliance with state licensure and accreditation standards such as CLIA, College of American Pathologists (CAP), and New York State Department of Health Clinical Laboratory Evaluation Program (CLEP). Experience with multiple inspections/surveys having direct interactions with CAP and New York State preferred.
- Knowledge of Clinical and Laboratory Standards Institute (CLSI) laboratory standards and Occupational Safety and Health Administration (OSHA) laws and regulations preferred.
- Certification in Quality (e.g., National Association for Healthcare Quality (NAHQ), American Society for Quality (ASQ) certification) is preferred.
- Certification in Six Sigma or Lean is preferred.
PURPOSE AND SCOPE:
The Laboratory Quality Assurance and Regulatory Affairs Manager is responsible for the oversight of the laboratory Quality Assurance program, proficiency testing, continuing education, occurrence reporting and inspection and accreditation processes.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Develop, implement and maintain a quality management and regulatory affairs system for all aspects of laboratory practice to comply with legal requirements of DOH, CAP, ISO CLIA, JCAHO and all other governing and regulatory and accreditation agencies.
- Develop, implement and review the Laboratory Administration policies and procedures. Ensure consistency with established policies and procedures.
- Analyzes, manages and reports data to identify improvement opportunities and measure progress of improvement projects.
- Instrumental in the development of a culture of quality and critical review within the laboratory.
- Develops, facilitates and coordinates the audit of laboratory processes and responsible for the dissemination of information relevant to quality of all laboratory staff.
- Develop, implement and document activities relating to the QA program to maintain and improve the lab's QA.
- Collaborate with Medical Director and Laboratory Director on performance improvement indicators.
- Coordinate regulatory inspections and ensure survey readiness within the laboratory.
- Develops budgets, schedules and performance standards. Exercises supervision in terms of costs, methods and staffing.
- Provides guidance and consultation to laboratory staff and management in their development and evaluation of plans of corrections in response to state, federal and accreditation surveys.
- Provides day to day guidance, support and direction to the Quality Assurance staff ensuring timeliness, accuracy and efficiency in the completion of all pertinent regulatory applications and related projects. Provides informal feedback on an ongoing basis and formal feedback in the form of the annual performance evaluation.
- Regularly interacts with, fosters and maintains good working relationships with internal and external customers, including state survey agencies and other regulatory bodies that have jurisdiction over the laboratory.
- Participates and presents at meetings with internal and external representatives. Maintains up to date knowledge of state regulations, quality improvement concepts, principles and practices to perform tasks and duties.
- Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
- Provide technical guidance.
- Assist with various projects as assigned.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- May be responsible for the direct supervision of various levels of [insert department/function name] staff.
- Bachelor's Degree in Medical Technology required. Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
- 6 - 8 years' related experience.
- 3+ years' supervisory or project/program management experience preferred.
- Knowledge of quality system, lean sigma or related program required.
- Good critical thinking and proven quality improvement experience.
- Excellent verbal and written communication skills.
- Knowledge of budget and financial management required.
- Ability to lead teams and projects required.
- Ability to change the thinking of, or gain acceptance from others in sensitive situations.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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