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 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.

ABOUT THIS JOB
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

HOW YOULL MAKE AN IMPACT
As a Quality Systems Engineer youll play a vital role in advancing our this position youll be responsible for monitoring and enhancing the operational effectiveness and regulatory compliance of in-process inspections final graft inspections and returned graft inspections. Manages monitors and enhances the effectiveness of all aspects of product-related complaint investigations nonconformances and/or equipment out of tolerance investigations. Provides overall support to maintaining the quality management system including performing/assisting with audits. Leads formal problem resolution teams.

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

WHAT YOULL DO

• 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.

WHAT YOULL BRING
Minimum Requirements:

• Bachelors Degree
• Three (3) Years Quality or operations related activities in tissue banking pharmaceutical medical device or clinical trial
• Valid State Drivers License

Preferred Experience/Skills/Certifications:

• 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
  

Key Knowledge Skills & Abilities:

• 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 effectively prioritize and juggle multiple time sensitive projects multi-task identify project interdependencies and potential risks/pitfalls
• Individual Development: Willingness to embrace and follow through on continuous learning

WHY JOIN LIFENET HEALTH

When you join LifeNet Health youre 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.

COMPENSATION

Salary Range: $65972 - $87962 annually

Final compensation will be based on factors such as geographic location qualifications and prior relevant experience. Actual compensation may be higher based on the successful candidates knowledge and 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.

As part of our commitment to safety we maintain a drug-free workplace and conduct pre-employment substance abuse screening.