Director, Quality Engineering

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 (Concert)

Department: Quality Engineering

Schedule: Monday-Friday, Full-Time

Clinical Status: Non-Clinical

HOW YOU’LL MAKE AN IMPACT
As a Director, Quality Engineering, you’ll play a vital role in advancing our mission. In this position, you’ll be responsible for ensuring the quality and compliance of product development, manufacturing, and sustaining engineering activities across the medical device, biologics, and tissue combination product portfolio. This role collaborates with cross-functional teams to ensure product and process outputs meet applicable regulatory requirements, including FDA 21 CFR Part 820, 21 CFR Part 1271, ISO 13485, and ISO 14971. Key responsibilities include leading risk management, verification and validation (V&V), and lifecycle quality oversight, while driving process improvement and ensuring consistent execution of the quality management system.

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

WHAT YOU’LL DO

• Production Quality & Engineering: Ensures end‑to‑end product quality across manufacturing and sustaining engineering by maintaining regulatory compliance and leading the development and continuous improvement of inspection plans, test methods, and quality controls. Oversees Quality System records, nonconforming material, and post‑market quality data, including complaints and CAPAs, to drive effective resolution of quality issues. Partners with suppliers and cross‑functional teams to ensure components, product changes, and design updates meet quality, reliability, and manufacturability expectations. Provides technical oversight for First Article Inspections, supplier quality activities, change controls, and V&V reviews to ensure ongoing lifecycle quality.
• Production Verification & Validation (V&V): Leads oversight of product and process V&V to ensure requirements and regulatory standards are met. Ensures test methods and protocols are scientifically sound, reliable, and compliant. Partners cross‑functionally to improve testing processes and tools. Provides technical leadership in reviewing V&V outcomes to ensure alignment with risk and lifecycle quality expectations.
• Risk Management: Ensure that risk management activities are executed for design and development, integrated into the production control process, and are continuously monitored throughout the product lifecycle in accordance with ISO 14971. Provide quality engineering support for Process Failure Mode and Effects Analysis (PFMEA) and other risk assessment tools to identify potential risks and develop mitigation strategies.
• Continuous Improvement: Identify and implement opportunities for continuous improvement in design quality processes and practices. Participate in cross-functional teams to drive quality improvements and operational efficiencies. Monitor and analyze quality metrics related to product, process, and manufacturing performance activities, and report findings to management.
• Regulatory Compliance and Audits: Support regulatory inspections and external audits related to product development, manufacturing, and sustaining activities. Ensure that Product Master Record files (PMR) and technical documentation are complete, accurate, and compliant with applicable regulations. Collaborate with regulatory affairs to ensure that product submissions meet regulatory requirements.
• People Leadership: Creates and maintains a satisfying workplace that fosters professional growth and job satisfaction for all members of the team. Ensures adequate staffing levels to maintain business continuity by hiring and retaining top talent. Uses established performance management processes (performance, development, succession, and career) to ensure staff development and team’s performance meets current and future standards. Manages and develops training plans and ongoing professional development goals for new and existing employees.

WHAT YOU’LL BRING
Minimum Requirements:

• Bachelor’s Degree
• SEVEN (7) Years – Management/Leadership experience with direct reports
• SEVEN (7) Years – Quality engineering within the medical device, tissue, biologics, pharmaceutical, or combination product industry
• SEVEN (7) Years – Design control process, V&V activities, risk management, corrective and preventive action investigation and root cause analysis, process flow charts, FMEAs, PFMAs, purchasing controls and control plans
• Auditor Training – Auditor training by a reputed organization (such as BSI, AIAG, etc.) Current or obtained within 6 months of employment

Preferred Experience/Skills/Certifications:

• Master’s Degree – Engineering or similar technical/science degree
• American Society for Quality – Auditor training
• Certified Quality Engineer (CQE)
   

Key Knowledge, Skills, & Abilities:

• Project Management: Ability to manage complex projects involving multiple, cross-functional teams with tight deadlines
• Communication Skills: Excellent verbal and written, communication skills; ability to communicate and build relationships with all professionals at different levels within the organization
• CAPA process: Root cause investigation and determination and corrective and preventative actions
• LEAN/Six Sigma: 8D method of problem resolution. Quality issues correction and prevent recurrence. Knowledge and experience of choosing KPIs in Safety, Quality, Delivery, Productivity, and cost areas
• Proficient in MS Office: PowerPoint, Excel, Word, Outlook, Microsoft Suite, as position requires
• 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 interdependence 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
• Teamwork: Ability to be collaborative 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: $132,690 - $176,921 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 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.