System Technical Quality and Regulatory Manager - MyMichigan Health

Summary:

The Technical Quality and Regulatory Manager will oversee for the System: All internal and external requirements in support of MyMichigan Medical Center Laboratories quality and compliance with regulatory requirements. This includes leading, managing and mentoring team members in the execution, measurement, and analysis of quality and compliance with regulatory requirements. 

Responsibilities:

(40%)* Support Laboratory Director to coordinate regional standardization, optimization and implementation of clinical standards, workflows, and policies within pre and post analytical processes

 

(30%) * Review and evaluate services, plans, processes that are affected by patient/environmental safety and regulatory issues. Participates in the development and review of system and facility clinical policies to ensure compliance with regulatory compliance.

 

(30%)* Monitor key performance metrics and find innovative solutions to improve quality and meet standards of accreditation in the areas of responsibility.

Certifications and Licensures:

• MT: Medical Technologist ASCP
  Equivalent Experience: Medical Laboratory Scientist. MLS, ASCP required.

Required Education:

• Education: BACHELOR DEGREE
  Equivalent Experience: Bachelor's Degree in Medical Laboratory Science required. Masters degree in Health Science, Business Administration or Marketing degree preferred.

 

Other Information:

OTHER DUTIES AND RESPONSIBILITIES:

Make operational and strategic decisions based on regulating bodies to ensure compliance.

 

Serve as central contact for vendors (technical).

 

Oversees various aspects of laboratory operations to ensure compliance.

 

Support and develop strategies to ensure ongoing compliance with Performance Improvement opportunities.

Assistwithrespondingtoanynon-scheduled visitsfromanyregulatoryagency.

 

Collaborate with team members to promote system standards and objectives for analytical processes.

 

Provide long range planning programs, synchronous with organizational goals and objectives.

 

Provides data and education to assure that all individuals in the organization understand the importance of regulatory compliance and their role in achieving quality excellence.

 

Ensure compliance with current safety requirements. Coordinates activities with other state and federal agencies and entities.

 

Maintain an awareness of emerging technology in the field of specialty.

 

Manage and promote best practice in specimen testing.

 

Continuous professional development as demonstrated by self-directed learning and participation in continuing education.

 

For Moderate complexity tests, this position may serve as the Technical Consultant (CLIA definition) or Technical Supervisor (https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M).

 

Plan and implement quality programs of the laboratory, including risk assessments, quality control and quality assurance.

Equivalent Experience and Other Comments (Education):

EXPERIENCE, TRAINING AND SKILLS:

Three (3) years clinical laboratory experience working in a Medical Center or similar setting with one (1) year of supervisory experience required.

 

Leadership skills needed to effectively direct a group.

 

Basic computer skills and knowledge.

 

Knowledge of basic marketing techniques and financial analysis.

 

Written and interpersonal skills needed to communicate successfully with individuals and groups and interact with people at all levels to communicate ideas and concepts in a clear and understandable manner.

 

This position must show knowledge, ability, and competence in treating patients who range in age from birth to 100+ years.

 

Tuberculosis (TB) testing must be done as required according to MIOSHA (Michigan Occupational Safety Health Administration) standards.

 

Mandatory Occupational Safety and Health Administration (OSHA) training must also be completed annually according to the Exposure Control Plan.

Other Comments:

PHYSICAL/MENTAL REQUIREMENTS AND TYPICAL WORKING CONDITIONS:

Exposure to stressful situations, including those involving public contact, as well as, trauma, grief and death.

 

 

Able to wear personal protective equipment that includes latex materials or appropriate substitute if required for your position.

 

 

Is able to move freely about facility with or without an assisted device and must be able to perform the functions of the job as outlined in the job description.

 

 

Overall vision and hearing is necessary with or without assisted device(s).

 

 

Frequently required to sit/stand/walk for long periods of time. May require frequent postural changes such as stooping, kneeling or crouching.

 

 

Some exposure to blood borne pathogens and other potentially infectious material. Must follow MyMichigan Health bloodborne pathogen and TB testing as required.

 

 

Ability to handle multiple tasks, get along with others, work independently, regular and predictable attendance and ability to stay awake.

 

 

Overall dexterity is required including handling, reaching, grasping, fingering and feeling. May require repetition of these movements on a regular to frequent basis.

 

 

Physical Demand Level: Sedentary. Must be able to occasionally (0-33% of the workday) lift or carry 0-10 lbs.