Quality Systems Engineer

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 Systems

Schedule:

Monday-Friday, 8‑hour day shift, hours may vary; nights, weekends, and on call as needed

Clinical Status:
Clinical

As a Quality Systems Engineer, you’ll play a vital role in advancing our mission. In this position, you’ll be responsible for monitoring and enhancing the operational effectiveness and regulatory compliance of in‑process inspections, final graft inspections, and returned graft inspections. You will manage, monitor, and enhance the effectiveness of all aspects of product‑related complaint investigations, nonconformances, and/or equipment out of tolerance investigations.

You will provide overall support to maintaining the quality management system, including performing/assisting with audits, and lead formal problem resolution teams.

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

• Investigation Management:
  Evaluates complaints, nonconformances, and/or equipment out of tolerance investigations to determine appropriate level and type of responses required and to ensure a thorough root cause analysis and effective corrective actions have been performed.
• Data Analysis:
  Manages and evaluates trending data effectively for investigation management activities, final inspection results and returned graft dispositions.
• Control of Documents:
  Creates and revises Standard Operating Procedures consistent with GMP/GTP, AATB, and ISO requirements.
• Problem Resolution:
  Participates on teams to resolve problems using formal methods, such as 8D.
• Graft Inspections:
  Facilitates and completes inspections of finished grafts associated with quality investigations as well as inspections of returned grafts.
• External Notifications and Approvals:
  Aids in the performance of activities related to assessing the need for approvals to and notifications from alliance partners and other external entities. Executes impact assessments, notifications, and approvals as assigned.
• Regulatory Compliance:
  Evaluates/audits QMS processes as assigned to ensure procedural compliance and effectiveness and provides support as required during second/third party audits.

Minimum Requirements:

• Bachelor’s Degree
• Three (3) Years – Quality or operations related activities in tissue banking, pharmaceutical, medical device, or clinical trial
• Valid State Driver’s License

• Bachelor of Science or Public Service – Engineering, Biological Sciences, or Allied Health field
• Certified Tissue Banking Specialist – American Association of Tissue Banks Standards for Tissue Banking
• One (1) Year – Facilitation of the monitoring, completion, and/or closure of quality investigations

• Industry regulations, standards, and guidelines:
  Able to review requirements, determine relevance to processes within the organization, and ensure compliance as applicable
• Communication:
  Excellent verbal and written communication skills; ability to communicate and build relationships with all professionals at different levels within and outside the organization
• Computer:
  Proficient in MS Office (PowerPoint, Excel, Word, Outlook)
• Statistics:
  Demonstrates a working knowledge of statistical analysis
• 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
• Problem Resolution:
  Demonstrates ability to anticipate and critically think through problems
• Analytical Thinking:
  Able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
• Time Management:
  Able to prioritize multiple, competing priorities and manage time/workload; able to…