Quality Systems Auditor

As a Quality Systems Auditor youll play a vital role in advancing our mission. In this position, youll 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., * 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 Healths 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.

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

Preferred Experience/Skills/Certifications:

• 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

Key Knowledge, Skills, & 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
• 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, 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;
• Time Management: Able to prioritize multiple, competing priorities and manage time/workload. Demonstrated ability to effectively prioritize and juggle multiple time sensitive projects, multi-task, identify project interdependencies and potential risks/pitfalls
• Proficient in MS Office: PowerPoint, Excel, Word, Outlook, Microsoft Suite

When you join LifeNet Health, you’re not just taking a job, youre joining a mission-driven community dedicated to making a global impact through regenerative medicine. Youll be part of a workplace that values authenticity, collaboration, and the drive to make a difference.

We recognize that great work happens when people feel supported. Thats why our total rewards package is designed to help you thrive both professionally and personally.

Heres how we support YOU:

• Affordable Medical, Dental, and Vision Coverage- Comprehensive care that wont break the bank.
• Profit Sharing Plan- Share in the success you help create.
• 403(b) Retirement Plan- Invest in your future with confidence.
• Paid Parental Leave- 6 weeks to bond with your newest family member.
• Corporate Sponsored Events- Celebrate milestones and build connections.
• Generous Paid Time Off- Because balance matters:
• 18 vacation days (based on position, tenure, and state laws)
• 9 sick days (subject to local and state regulations)
• 9 holidays (7 standard + 2 floating)
• Flexible Work Program- For approved roles, how and where you perform best.
• Tuition reimbursement- We invest in your growth and education.
• Career & Leadership Development- Expand your impact and potential.
• Wellness Program- Prioritize your health with holistic resources.
• Employee Assistance Program (EAP)- Support for you and your household.
• Incredible teammates- Collaborate with passionate, dedicated professionals.

Note: All benefits are subject to eligibility requirements and may be modified at any time, with or without notice, unless otherwise required by law. This job posting does not constitute an employment contract and does not alter the at-will nature of employment at LifeNet Health., Salary Range: $57,363 - $95,505, $57,363.00

Every day, YOU help us to save lives, restore health, and bring hope to patients and families around the world. At LifeNet 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.