Quality Assurance Coordinator
Job Details
Experienced
Headquarters - Pittsburgh, PA
Full Time

POSITION SUMMARY

 

The position of Quality Assurance Coordinator for the Center for Organ Recovery & Education (CORE) is one of moderate responsibility.  The Quality Assurance Coordinator is responsible to and works under the direction of the Center’s Associate Director of Quality Systems.  As with all CORE employees, however, ultimate supervisory responsibility is by the President/CEO.  The Quality Assurance Coordinator is responsible to ensure that COREs Services and Procedures meet both internal and external requirements and coordinates the activities required to meet quality standards, regulatory compliance, and customer expectations.  The Quality Assurance Coordinator will ensure the consistency and alignment of CORE Policies, Standard Operating Procedures and Processes.

 

SCOPE OF RESPONSIBILITY

A Quality Assurance Coordinator can be assigned any of the following tasks based on department and organization needs:

  • Design and maintenance of an Integrated Quality System including the creation and coordination of Business System Manuals, Standard Operating Procedures and Work Instructions.
  • Administration and Management of CORE’s Document Control System.
  • Administration of COREs Record Control Systems.
  • Administration of COREs, CAPA, Change Control, Internal Audit, and Supplier Control Systems.
  • Assisting the Associate Director of Quality Systems in maintaining audit readiness.
  • Auditing of Donor Records for accuracy and completeness.
  • Working with Clinical Staff to correct or clarify missing or incorrect information related to Donor activity.

 

The Quality Assurance Coordinator will play a significant role in the development and sustainment of CORE’s Quality and Process Improvement Culture.  Through the use of continuous improvement tools, the Quality Assurance Coordinator will work to ensure the consistency, integration and regulatory compliance of all CORE processes and written documentation. In addition to the review and audit of donation related medical records, the Quality Assurance Coordinator will work with Subject Matter Experts to identify and document best practices as well as determining corrective action plans when opportunities for improvement are identified.

 

 

The Quality Assurance Coordinator must have a high attention to detail in order to ensure that information is accurate. Donor records must be complete, legible and accurate to ensure the safety of recipients and consistent regulatory compliance. The Quality Assurance Coordinator may be required to enter information into national databases. Quality Assurance Coordinators review partner request reports for missing information and ensure the corrections and/or additions are sent to the partners in a timely manner. These requests could include obtaining hospital medical records, autopsy reports EMS records, primary care records etc. Quality Assurance Coordinators must be able to establish and maintain professional relationships with these key external partners. Quality Assurance Coordinators must maintain a high level of confidence and integrity and are responsible for immediately communicating to the Associate Director of Quality Systems and/or Clinical Leadership any findings in donor information that have the potential for transmitting infectious or contagious diseases or pose an immediate impact on regulatory compliance. Quality Assurance Coordinators are responsible for working collaboratively with the various clinical departments in order to continuously improve the quality of the donor records.

 

The Quality Assurance Coordinator must have excellent customer service skills and be able to communicate effectively with all external partners. Quality Assurance Coordinators must have a sense of urgency, as many of functions performed at CORE are time sensitive.

JOB QUALIFICATIONS

 

The incumbent for the position of Quality Assurance Coordinator should have, as a minimum, Associates Degree in an engineering or science field. In lieu of a degree, some sort of formal education in continuous improvement tools and equivalent experience will be considered.  Two (2) years of experience in medical device manufacturing or related industry, two (2) years of experience working with ISO 9001, 13485 & 21 CFR Part 820.  Previous experience and knowledge of complaint handling and CAPA’s. Candidates should also possess a broad knowledge of Quality Assurance, Regulatory Compliance, or quality control inclusive of GMP and FDA regulations.

Strong preference will be given to Quality related certifications, Medical Device Manufacturing experience and experience with the National Baldrige Award criteria.

 

DEGREE OF JOB DIFFICULTY

 

The Quality Assurance Coordinator’s work is checked by the Associate Director of Quality Systems. The degree of difficulty falls into the significant range.  Inadvertent errors or mistakes could result in loss of relationships with donor hospitals, tissue processors, eye banks or OPOs.  Legal action or loss of CORE’s accreditation is possible if actions are not properly carried out. 

 

 

SUPERVISORY REQUIREMENTS

 

None.

Chris Yanakos- Be a Hero. Be an Organ Donor
Video
Apply