Quality Systems Engineer

LifeNet Health•Virginia Beach, VA

2d•$65,972 - $87,962

About The Position

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. 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.

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
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

Nice To Haves

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

Responsibilities

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.

Benefits

Affordable Medical, Dental, and Vision Coverage- Comprehensive care that won’t 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.