Quality 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

Department: Quality Engineering

Schedule: Monday-Friday, 8:15AM – 5:00PM      

Clinical Status: Clinical
 

HOW YOU’LL MAKE AN IMPACT
As a Quality Engineer you’ll play a vital role in advancing our mission. In this position, you’ll be responsible for playing a key role in the Quality Systems and Regulatory Compliance teams through ensuring compliance of products with all applicable federal, industry, and company procedures, guidelines, and regulations during the development, receipt, storage, manufacture, and distribution of products. The Quality Engineer role serves as an internal consultant and is responsible for risk mitigation through various processes (e.g., Employee Safety, Supplier Quality, and Risk Management processes. This role ensures that introduction of a new product into production is compliant with GTP, GMP, ISO, and OSHA requirements. Participates on cross-functional teams to evaluate new products, including medical devices, for compliance with the Quality Management System and regulation bodies.

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

WHAT YOU’LL DO

• Design Control and Production: Provides quality engineering support to new product development teams in the design control process. Provides quality and reliability engineering support to value streams including approval protocols for various process and product qualification studies (e.g., IQ, OQ, PQ). Ensure executable protocols comply with applicable federal, industry, and company procedures, guidelines, and regulations. Serve as a member of the Design Control Review Team. Provides quality engineering support on root cause analysis and problem solving for Operations groups as needed.
• Risk Management: Ensure compliance with ISO 13485 and ISO 14971. Leads risk management activities during Design Control and post-production activities. Reviews and provide data analysis for complaints and nonconformance issues as related to post-production activities. Maintains the risk management file for products, including medical devices. Collaborates with design control teams in developing and executing design risk analyses, risk management plans, dFMEA, pFMEA, hazard traceability matrix, risk management file reviews during design control, risk benefit analysis, risk management report, authors period safety report updates (PSURs) and pharmacovigilance reports for competent authorities. Performs risk assessment as part of post market monitoring in support of complaint risk analysis, field corrective actions, design changes, product life cycle sustaining efforts, and others. Supports MDSAP audit.
• Supplier Quality Program: Effectively executes the Supplier Quality program including on-site, desktop, virtual, and other Supplier Quality Audits. Manages supplier audits and agency communication with suppliers. Conducts effective execution of the supplier selection and approval process. Initiates, measures, and communicates supplier performance on key metrics and the corresponding continuous improvement plans/audit findings. Has oversight for the needed improvement action throughout the supply chain. Responsible for maintenance of supplier FMEA and supplier audit selection and prioritization. Generates quality master agreements when appropriate. Provides expertise and approval on supply non-conformities or alternate supply selection.
• Non-conforming Review Board: Conducts NCRB review for non-conforming supplies received and determine appropriate disposition of supplies. Performs NCRB review for tissue related items requiring cross-functional team review and approval. Determines disposition of medical devices and products related to non-conforming issues.
• Employee Safety & Equipment Compliance: Leads the Corporate Employee Safety Program and serves as the Corporate Safety Officer, ensuring corporate with OSHA regulations and company policies. Acts as the corporate safety officer. Conducts quarterly employee safety meetings. Leads safety meetings, reports required incidents, and oversees equipment validations and the appropriate disposition of equipment-related nonconformances and out-of-tolerance conditions.

WHAT YOU’LL BRING
Minimum Requirements:

• Bachelor’s Degree – Engineering or similar technical/science degree
• Auditor Training – Auditor training by a reputed organization (such as BSI, AIAG, etc.) – Current or obtain within six months of employment

Preferred Experience/Skills/Certifications:

• Master’s Degree – Engineering or similar technical/science degree
• Auditor Training by ASQ – American Society for Quality
• Certified Quality Engineer certification
• TWO (2) Years – Quality Engineer or related medical device experience
• TWO (2) Years – Supplier Management experience
• TWO (2) Years – Project Management experience
• TWO (2) Years – Experience with LifeNet Health, preferably in an Engineering role
• ONE (1) Year – Risk Management experience
• ONE (1) Year – Employee Health & Safety experience
   

Key Knowledge, Skills, & Abilities:

• Proficient in MS Office – PowerPoint, Excel, Word, Outlook, Microsoft Suite
• Time Management – Able to prioritize multiple, competing priorities, and manage time/workload. Demonstrated ability to juggle multiple time sensitive projects, multi-task, identify project interdependences and potential risks/pitfalls.
• Attention to Detail: Able to perform task thoroughly and with care; checks work to ensure high degree of accuracy/completeness, and early/on-time delivery
• Communication Skills: Excellent verbal and written communication skills; ability to communicate and build relationships with all professionals at different levels within the organization. Ability to be collaborate and work as part of a team to resolve issues, complete tasks and meet business needs.

WHY JOIN LIFENET HEALTH

When you join LifeNet Health, you're not just taking a job, you’re joining a mission-driven community dedicated to making a global impact through regenerative medicine.  You’ll 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. That’s why our total rewards package is designed to help you thrive both professionally and personally.

Here’s how we support YOU:

• 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.
   

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: $57,362.76 - $95,604.60

Final compensation will be based on factors such as geographic location, qualifications, and prior relevant experience. The pay range for this position is $57,362.76 (entry level qualifications) to $76,483.68
(experienced in this role). Actual compensation may be higher based on the successful candidate’s 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.