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 YOULL MAKE AN IMPACT
As a Director Quality Engineering youll play a vital role in advancing our this position youll 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 YOULL DO

• Production Quality & Engineering: Ensures endtoend 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 postmarket quality data including complaints and CAPAs to drive effective resolution of quality issues. Partners with suppliers and crossfunctional 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 crossfunctionally 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 teams performance meets current and future standards. Manages and develops training plans and ongoing professional development goals for new and existing employees.

WHAT YOULL BRING
Minimum Requirements:

• Bachelors 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:

• Masters 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 youre not just taking a job youre joining a mission-driven community dedicated to making a global impact through regenerative medicine. Youll 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. Thats why our total rewards package is designed to help you thrive both professionally and personally.

Heres how we support YOU:

• Affordable Medical Dental and Vision Coverage- Comprehensive care that wont 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: $132690 - $176921 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 candidates 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.