Quality Systems Auditor (10108-2026631)

About the role

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.

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.
• Affords support for 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: 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)
• 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

Why Join LifeNet Health

• Note: All benefits are subject to eligibility requirements and may be modified at any time, with or without notice, unless otherwise required by law.

Compensation

Salary Range: $57,363 - $95,505 Final compensation will be based on factors such as geographic location, qualifications, and prior relevant experience.

Equal Opportunity Employer

LifeNet Health is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.