Overview
Laboratory Assistant Jobs in Bedford, TX at GI Alliance
POSITION SUMMARY
The position of Director of Quality Systems is responsible to, and works under the direction of, the Chief Innovation and Performance Officer. They function as the subject matter expert for all quality assurance and quality control activities to include, but not limited to document control, supplier quality, recall and containment, validation, regulatory and accreditation, internal audits, record control, CAPA, and change control. They independently ensure all licenses and accreditations are kept current and manage all activities related to external audits and inspections. They establish collaborative working relationships with leadership team members who are assigned to each regulation and standard. They are responsible for keeping CORE educated on and compliant with all regulatory issues, standards, and updates.
SCOPE OF RESPONSIBILITY
The Director of Quality Systems is expected to function on a highly independent level, making decisions regarding compliance with regulations and standards. They will track all CORE licenses and accreditations and will work with the appropriate department leader to ensure that these are all kept current. They will work collaboratively with all members of the leadership team, and all CORE employees when appropriate, to ensure that CORE is prepared for scheduled inspections and external audits.
The Director of Quality Systems shall establish and maintain control of documents and data, including, where applicable, documents of external origin such as standards and customer specifications.
The Director of Quality Systems shall ensure that all suppliers of purchased or otherwise received product and services conform to specified requirements. Additionally, the potential suppliers culture must align with COREs values.
The Director of Quality Systems shall manage the methods that address the identification, documentation, evaluation, segregation, and disposition of nonconforming product.
The Director of Quality Systems shall ensure the methods to ensure that specific processes will consistently produce a product meeting its predetermined specifications and quality attributes.
The Director of Quality Systems shall define the key compliance processes, measures, and goals for meeting and surpassing regulatory, voluntary standard and legal requirements, and that CORE operates in a highly regulated environment and maintains full licensure accreditation.
The Director of Quality Systems shall ensure verification of quality activities and related results comply with planned arrangements and determine the effectiveness of the quality system.
The Director of Quality Systems shall ensure quality records are maintained to demonstrate conformance to specified requirements and the effective operations of the quality system. Quality records are legible and are stored in a manner so that they are readily identifiable and retrievable. Quality record retention times are described in documented procedures.
The Director of Quality Systems shall ensure that equipment is routinely calibrated, inspected, checked, and maintained. Included are provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use. Calibration procedures include specific directions and limits for accuracy and precision.
The Director of Quality Systems shall ensure changes to documents and processes are reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise.
The Director of Quality Systems will log, track, and submit reports regarding deviations, recalls, errors, complaints etc. per FDA, EBAA, AATB, CMS, UNOS, and all other regulatory body requirements and consult the Chief Innovation and Performance Officer, if necessary. They will work with the appropriate department leader to ensure that these reports are completed timely and accurately.
The Director of Quality Systems will provide supervision, direction, and guidance to the Quality Assurance and Quality Control Coordinators. They will conduct a monthly department meeting and complete monthly rounding on direct reports.
The Director of Quality Systems will be an active member of the Morning Huddle. They will attend and participate in monthly leadership meetings and quarterly strategic planning. They will participate in the Performance Excellence Journey as assigned.
The Director of Quality Systems will be an active member of assigned national committees that may include AOPO, AATB, EBAA, and will attend conferences/meetings as assigned.
JOB QUALIFICATIONS
BS degree is preferred in a science or engineering field.
Minimum of ten years experience in quality management preferably in a regulated environment. Compliance. OPO/tissue banking or healthcare experience also preferred.
Two years experience providing supervision is preferred.
Demonstrates excellent time management and organizational skills.
Independent functioning and ability to interpret regulations and relevance to CORE processes.
Working knowledge of computer-based skills, including electronic charting, document control, word processing, and spreadsheet development.
Excellent communication skills both oral and written.
Ability to communicate and work with all levels of the workforce.
Ability to travel to local, regional, and national meetings is required.
DEGREE OF JOB DIFFICULTY
The position of Director of Quality Systems falls in the range of moderate-high complexity. Inadvertent mistakes or errors could result in loss of licenses, accreditations, funding and/or relationships with donor hospitals and other agencies.
SUPERVISORY REQUIREMENTS
The Director of Quality Systems will provide supervision for the Quality Assurance and Quality Coordinators.
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Title: Laboratory Assistant
Company: GI Alliance
Location: Bedford, TX
