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 Life Net 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.

Location:

Virginia Beach, VA (Concert)
Department:
Quality Engineering

Schedule:

Monday-Friday, Full-Time
Clinical Status:
Non-Clinical

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.

• 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…