Director, Quality Engineering

LifeNet Health•Virginia Beach, VA

2d•Onsite

About The Position

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.

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
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

Nice To Haves

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

Responsibilities

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.
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.
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.
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.
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.
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.

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.