Quality Systems Auditor

AT LIFENET HEALTH, YOU ARE THE ADVANTAGE

Every day, YOU help us to save lives, restore health, and bring hope to patients and families around the world. At Life Net Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity.

Together, we are united by a mission greater than ourselves, a purpose rooted in healing.

Location:

Virginia Beach, VA (Sabre)
Department:
Quality

Schedule:

Monday-Friday | 8:15AM-5:00PM; hours may vary, nights, weekends, and on-call as needed
Clinical Status:
Enhanced Clinical

As a Quality Systems Auditor you’ll play a vital role in advancing our mission. In this position, you’ll be responsible for ensuring internal quality audits are effective, on schedule, and meeting all regulatory requirements. This position supports the performance of desktop audits and surveys of tissue suppliers and intermediaries and may assist with conducting onsite or virtual audits of external partnering agencies upon request.

This position supports the overall business operations by utilizing an analytical approach to problem resolution by conducting quality audits in accordance with internal SOPs, contracts, voluntary accreditation standards and required government regulations. This position also supports the overall implementation and maintenance of quality systems including activities such as conducting investigations, performing CAPA administrative functions, and supporting second/third party audits.

Your work will have purpose every single day, contributing directly to life-changing outcomes.

• Performs all facets of internal quality audits, including plan development, initiation, observations/interviews, analysis of results, report compilation/distribution, presentation of results to auditees, approval and verification of corrective/preventive actions, and audit file maintenance.
• Assists with the performance of tissue supplier audits and tissue distribution intermediary audits/desktop surveys.
• Provides guidance and assistance to assigned partnering departments in Life Net Health’s Zone Assessment Program.
• Supports third party audits of Life Net Health by government agencies, voluntary accreditation agencies and business partners as needed.
• Leads projects with cross-functional teams and promotes problem resolution methods, such as 8D, to solve problems throughout the organization. Participates on project teams as assigned.
• Creates and revises Standard Operating Procedures consistent with QSR/GTP, AATB, and ISO requirements.
• Reviews elements of CAPA investigations for completeness and accuracy, verifies effectiveness of corrective actions, and works with key stakeholders to ensure related documentation adequately resolves the related issue(s);
  Serves as a QS technical resource/SME for CATSWeb related activities and provides training as required.

Minimum Requirements:

• Bachelor’s Degree
• 2 Years - quality or operations related activities in tissue banking, blood banking, medical device, clinical trial, or pharmaceutical (6 YEARS EXPERIENCE WITHOUT DEGREE)

• Bachelor of Science – Business Management, Public Health, Quality Health, Quality Engineering, Natural Sciences, or Allied Health Field
• American Society for Quality (ASQ) Certification – Certified Quality Auditor
• AATB Certified Tissue Banking Specialist

• Auditing:
  Demonstrates understanding of quality auditing concepts;
  Ability to effectively apply auditing concepts to both familiar and unfamiliar areas of focus preferred
• Analytical Thinking:
  Able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
• Attention to detail:
  Able to perform tasks thoroughly and with care; checks work to ensure high degree of accuracy/completeness and early/on-time delivery
• Industry regulations, standards, and guidelines:
  Able to review requirements, determine relevance to processes within the organization, and ensure compliance as applicable;
  Familiarity with applicable tissue banking/medical device related regulations,…