Quality Assurance Manager

ESSENTIAL JOB FUNCTIONS

Conduct weekly reviews to ensure quality is being maintained and review with Operations Manager.

Establish Quality Operations and Quality Control function at given location, including assisting in hiring, developing, and conducting training.

Determine process validation and maintenance of controlled requirements.

This process to be documented and retained based on good documentation processes as established

Partner with relevant internal and external teams to compliance. To be reviewed weekly.

Review/approve inspection plans and methods to ensure thorough and efficient inspection processes and to ensure those inspections are commensurate with the associated level of risk.

Work with Operations Management as needed to achieve root cause corrective action.

Develops and analyzes reports to monitor and evaluate quality performance in meeting established goals related to the quality management work plan and contractual requirements

Coordinates guidelines, studies, and performance improvement activities in concert with the utilization management, quality management, pharmacy services, case management and device management programs.

Assists in the tracking and monitoring of systems for quality improvement activities according to regulatory requirements, policies and procedures, and contractual agreements.

Monitors productivity of staff and productivity minimum expectations for each role. Provides regular feedback and support to staff in meeting performance expectations.

Prepares, compiles, reviews, and submits monthly and quarterly reports for the Quality/Programs.

Participate in internal and external audits as a subject matter expert on quality operations and quality control functions.

Identify problems, and propose resolutions that are timely, cost-effective, and meet quality requirements.

All other duties as assigned

PHYSICAL REQUIREMENTS

Job requires the ability to use vision, adjust focus and work on a standard computer screen

Job may require extended sitting or standing, use of standard office equipment

Job will require punctuality and regular attendance on-site at the assigned work location.

[The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.]

OTHER SKILLS AND ABILITIES

In-depth knowledge of quality control procedures, sampling procedures and sampling methods

In-depth knowledge of the interactions/interfaces between Risk Management, Quality Engineering and Quality Control processes

Strong analytical problem-solving skills

Ability to investigate complex issues using proven tools/methods, develop potential solutions, and implement fixes

Demonstrated team leadership and development skills including training of functional personnel to applicable standards and career planning for team members

QUALIFICATIONS

Bachelor of Science degree or related discipline preferred

5 years of supervisory experience

CERTIFICATIONS & LICENSES

Professional Certification may be required in some areas.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.