Director, Quality Engineering

Overview

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 continuously monitored throughout the product lifecycle in accordance with ISO 14971. Provide quality engineering support for 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: Create and maintain a satisfying workplace that fosters professional growth and job satisfaction. Ensure adequate staffing levels to maintain business continuity by hiring and retaining top talent. Use established performance management processes to ensure staff development and team performance meets current and future standards. Manage and develop 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, PFMEAs, purchasing controls and control plans
• Auditor Training – Auditor training by a reputable 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; ability to communicate and build relationships with professionals at all levels
• CAPA process: Root cause investigation and corrective/preventive actions
• LEAN/Six Sigma: 8D problem resolution and KPI knowledge across Safety, Quality, Delivery, Productivity, and cost
• MS Office proficiency: PowerPoint, Excel, Word, Outlook, Microsoft Suite
• Time Management: Prioritize multiple priorities and manage time/workload
• Attention to Detail: Thorough work with high accuracy and on-time delivery
• Teamwork: Collaborative and able to work as part of a team

WHY JOIN LIFENET HEALTH

LifeNet Health is a mission-driven organization focused on regenerative medicine. We value authenticity, collaboration, and the drive to make a difference. Our total rewards package supports both professional and personal growth.

Here’s how we support YOU:

• Affordable Medical, Dental, and Vision Coverage
• Profit Sharing Plan
• 403(b) Retirement Plan
• Paid Parental Leave
• Corporate Sponsored Events
• Generous Paid Time Off: 18 vacation days, 9 sick days, 9 holidays
• Flexible Work Program
• Tuition reimbursement
• Career & Leadership Development
• Wellness Program
• Employee Assistance Program (EAP)
• Incredible teammates

Note: All benefits are subject to eligibility requirements and may be modified at any time. 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.

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.

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