Quality Systems Auditor

Quality Systems Auditor

Location: Virginia Beach, VA

Department: Quality Systems

Job Type: Full-Time

Shift: Mon-Friday 8:15AM-5PM; hours may vary; nights, weekends, and on-call as needed

Travel: Up to 30% travel

LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.

LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (“OPO”) and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process.  LifeNet Health has over 1200 employees and has a growing global presence.

How you will contribute to LifeNet Health’s success:

As Quality Systems Auditor, you will ensure 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.

What you’ll do:

• 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 LifeNet Health’s Zone Assessment Program.
• Supports third party audits of LifeNet 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.

What you’ll bring (Minimum Requirements):

• 2 YEARS WITH DEGREE – quality or operations related activities in tissue banking, blood banking, medical device, clinical trial, or pharmaceutical (6 YEARS EXPERIENCE WITHOUT DEGREE)

Preferred

• 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

These would be nice too (Knowledge Skills and Abilities):

• 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
• 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, standards and guidelines 21 CFR 1271, 21 CFR 820, ISO 13485, AATB Standards preferred
• Communication: Demonstrates excellent verbal and written communication skills; Ability to effectively communicate with a variety of internal and external customers preferred
• Problem Resolution: Demonstrates ability to anticipate and critically think through problems; Proficient with advanced problem resolution tools 8D, Ishikawa preferred
• Technical Writing: Able to create and revise documents, presentations and training materials according to established requirements; Proficiency with word processing, publishing and other relevant software types Microsoft Office, Adobe Pro preferred

Why work at LifeNet Health?

We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You will not find another company with a culture as strong as ours.

• 403(b) and Profit-Sharing Plan
• Affordable medical, dental, and vision coverage
• Corporate sponsored events for employees
• Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
  • 18 vacation days
  • 9 sick days
  • 7 paid holidays
• Tuition reimbursement
• Personal career, skill, and leadership development opportunities
• Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)
• Employee Assistance Program (EAP) for employees and members of their household
• Dedicated and passionate co-worker

Salary: $57,363 - $76,484/annually

* The pay rate for the successful candidate will depend on geographic location and the candidate’s qualifications and prior relevant experience. *Actual compensation may be higher based on the successful candidate's knowledge and relevant experience.

This position is eligible for an annual bonus once eligibility criteria are met. 

All benefits are subject to eligibility requirements and LifeNet Health reserves the right to modify or change these benefits programs at any time, with or without notice, unless otherwise required by law.  Further, nothing in this posting is intended to alter the “at will” relationship of a successful candidate and this posting does not constitute a specific promise.

LifeNet Health is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status.  We maintain a drug-free workplace and perform pre-employment substance abuse testing.