Quality Assurance Director- Healthcare jobs in Kennewick, WA

PRIMARY RESPONSIBILITIES

• Assisting management with indoctrination and training.
• Qualification of Lead Auditor personnel and for ensuring that proper training has been successfully completed prior to the initiation of any audits.
• Responsible for review and approval of all safety-related procurement documents.
• Development of QA procedures necessary to implement the QA Program.
• Identifying the need for revisions or additions to the QA procedures.
• Approving new or revised procedures.
• Determining the need for Desk Instructions (DIs).
• Review and evaluation of Supplier’s Quality Assurance Program.
• Maintain TG ESL.
• Perform annual desk reviews of Suppliers on the TG ESL including the review of any nonconformances.
• Perform on-site audits tri-annually of Supplier on the TG ESL.
• Responsible for determining when surveillances are to be conducted.
• Responsible for certification and issuance of the TG Certificate of Conformances.
• Responsible for reviewing and approving Commercial Grade Dedication (CGD) Plans, checklists, surveillance activities, and witnessing and/or performing inspections on CGD items or services. Also responsible for ensuring that personnel (both TG and Subcontractor) are qualified/certified to perform required duties.
• Responsible for ensuring nonconforming conditions are identified, documented, controlled and resolved.
• Ensure inspection/test documentation is completed for all NCR repair dispositions to ensure repairs were accomplished in accordance with the disposition.
• Ensures that nonconforming items are physically segregated from acceptable items when possible. When segregation is not possible or practical, other means such as tagging or identifying the area shall be done.
• Responsible for reporting the adverse condition or trends to the appropriate levels of management.
• Responsible for confirming that a nonconformance exists and for initiating a Deficiency Report (DR). Provides input into the cause of the deficiency, extent of condition, and the action to be taken to prevent recurrence. Verifies that the actions to preclude recurrence have been completed.
• Responsible for initiating a Corrective Action Report (CAR) after evaluation and determination that the adverse condition is valid. Responsible for notifications and assigning ownership for corrective actions. Responsible for follow up, verifying corrective action(s) are completed, all issues resolved and the CAR is closed.
• Responsible for planning, scheduling, conducting, approving, reporting, tracking, and follow up of any identified deficiencies that result in an audit finding of TG.
• Ensures all audit personnel are qualified in accordance with the TG-DOE-QAP-002-204, Audit Personnel Qualification.
• Responsible for reviewing and approving the initial safety software requirements specification.
• Responsible for reviewing and approving safety software baseline documents and any software change requests.

Lead Auditor

• Responsible for organizing, preparing, directing, and managing the audit.
• Responsible for issuing the audit plan, checklists, audit report, findings and observations identified during the audit.
• Review all responses to audit findings or concerns and perform follow up on corrective actions when required.

REQUIRED QUALIFICATIONS

• A Bachelor’s degree, or equivalent
• 3-5 years Hanford or other Government Experience Preferred
• Direct working knowledge of NQA-1 Program