Quality Systems eQMS System Administrator

Full Time
Renton, WA 98057
Posted
Job description

qs eqms system administrator

Location:
Virginia Beach, Virginia or Renton, WA
Department: Quality Systems
Job Type: Full-Time
Shift: 8:15AM – 5:00PM, Monday - Friday
Clinical Classification: Non-Clinical


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:

The Quality Systems EQMS System Administrator is responsible for the administration of LifeNet Health’s Enterprise Quality Management System (EQMS). Facilitates and/or aids in the configuration and implementation of the various modules and field-based solutions associated with the following functional areas: documents, management of change, training, nonconformance, complaints, corrective/preventive actions, audits, supplier management, bill of materials (BOM), design history files, risk management, and other applicable QMS areas. Develops and maintains associated EQMS processes and procedures for LNH end users. Provides training to LNH personnel on using the system and serves as a subject matter expert. Ensures EQMS training is managed in compliance with applicable standards, regulations, and guidelines.

What you’ll do:

  • EQMS System Administration: Serves as a subject matter expert for the EQMS. Facilitates and/or supports EQMS planning, configuration, and implementation activities. Facilitates the development and maintenance of standardized processes and procedures for EQMS modules in compliance with applicable regulations, standards, and guidelines. Reviews proposed changes to the validated system and participates in the planning and execution of changes. Drives EQMS related communication and cross-collaboration across functional areas.
  • EQMS Compliance Oversight: Provides Quality oversight of the EQMS system to ensure continued compliance with applicable regulations, standards, and guidelines. Supports regulatory inspections of LifeNet Health and facilitates operational readiness activities associated with the EQMS.
  • Training: Trains and coaches LNH personnel to perform administrative or basic end-user tasks associated with the various modules of the system based on business need. Completes cross-functional training and provides back-up support to team members as assigned.
  • Troubleshooting: Troubleshoots minor quality issues and provides general guidance to end users of the system. Monitors reoccurring issues, system/data or process gaps and identifies measures for continuous improvement. Works closely with LNH Information Systems personnel for advanced troubleshooting needs and to consult regarding enlisting EQMS vendor support as needed.
  • KPIs: Establishes, monitors, and analyzes key performance indicators related to EQMS activities. Recommends and initiates process improvements based on trends identified.

What you’ll bring (Minimum Requirements):

  • Bachelor’s Degree in Healthcare, Engineering, Information Systems, Business, or related field
  • 4 years’ experience in tissue banking, blood banking, medical device, clinical trial, or pharmaceutical
  • 2 years’ experience in Quality related tasks (e.g., audition, CAPAs, nonconformances, complaints, or training
  • Project Management Certification (within 2 years of hire) – Certified Associate in Project Management (CAPM) or Project Management Professional (PMP) – current or obtain within first two years of start in role
  • EQMS Administrator – EQMS System Administrator Certification – current or obtain within one year of start date in role

Preferred Experience/Skills/Certifications:

  • 2 years’ experience in training adult learners and/or management of training documentation and/or development of training modules within a Learning Management System or creator platform
  • 1 year experience in an administrator role for an EQMS or similar enterprise system
  • Quality Auditor Training – ISO 13485 2016 Lead Auditor Training (i.e., VSI or ASQ)
  • MasterControl Certified System Administrator – Levels 1-5 or Expert Designation

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

  • Computer Skills: PowerPoint, Excel, Word, Outlook, Microsoft Suite, EQMS or LMS Administration, preferred.
  • Problem Resolution: Demonstrates ability to anticipate and critically think through problems.
  • 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.
  • 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.
  • Communication: Excellent written and verbal communication skills. Ability to communicate and build relationships with all professionals at different.

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
  • 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-workers


We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

This position can be filled at our Virginia Beach, VA or Renton, WA location.

The pay rate for the successful candidate located in our Renton, WA facility will depend on the candidate’s qualifications and prior experience. The pay range for this position in Renton, WA is $84,082 annually (entry-level qualifications) to $140,136 annually (experienced in this role).

This position is also eligible for an annual bonus based on criteria being 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.

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