The LifeNet Health mission is simple: Saving Lives. Restoring Health. Giving Hope. Its mission, along with its core values of safety, quality, innovation and service continue to create an unmatched record in transplant solutions, which cannot be achieved without talented, dedicated team members who share the same values and attributes that guide the LifeNet Health team every day.

If you have a commitment to customer care, quality and innovation as well as integrity and passion, then you’ve come to the right place.

We are currently seeking a full time Quality Systems Auditor to join the LifeNet Health team in our Renton, WA location.

As a quality Systems Auditor, you would be responsible for ensuring the Quality Systems audit program (e.g., Internal Audits, Tissue Supplier Audits, Design History File (DHF) audits, Tissue Distribution Intermediary Audits, etc.) is effective, on schedule, and meeting all regulatory requirements. 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. Requires 10-30% travel.

You would be expected to perform all tasks assigned to you, including but not limited to:

• Performs all facets of 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 QS management with development of quality audit schedules and ensures audits are completed according to schedule.
• 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.
• Develops, maintains, and analyzes quality metrics for Quality Systems related activities.
• Evaluates the effectiveness and efficiency of regulated processes throughout the organization using a LEAN approach and makes recommendations for improvement.
• 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.
• Supports third party audits of LifeNet Health by government agencies, voluntary accreditation agencies and business partners as needed.