![]()
Director, Production Quality
Location: Virginia Beach
Department: Quality Engineering
Job Type: Full-Time
Shift: Monday-Friday, Full Time
Clinical Classification: Non-Clinical
LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (OPO) and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues, and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence.
How you will contribute to LifeNet Health's success:
The Director of Production Quality will be responsible for ensuring the quality and compliance of both new product development and sustaining engineering projects in the medical device/biologics/tissue combination product industry. This role involves partnering with cross-functional teams to ensure that production processes and outputs meet all applicable regulatory requirements, including but not limited to FDA 21 CFR Part 820, 21 CFR Part 1271, ISO 13485, and ISO 14971. This role will also play a critical role in risk management, design verification and validation (V&V), production and continuous improvement initiatives.
What you'll do:
Production Quality:
- Ensure that all production activities are conducted in compliance with regulatory requirements and company standards.
- Works with Procurement & applicable Business Units to ensure that components meet established requirements.
- Proactively drives the evaluation, monitoring, and continuous improvement of quality control inspection methods and efficiency opportunities.
- Reviews and coordinates intradepartmental approval of internal and externally generated NCRs, CAPAs, Deviations, and other Quality System inputs using established procedures and work instructions.
- Ensures the nonconforming material identified from receiving, in-process, and finished device acceptance is identified, documented, and communicated to affected parties for timely and effective resolution
- Ensures quality control inspection plans, tests and methods are adequately developed (including test/inspection equipment), implemented, maintained and utilized statistical methodology, where appropriate, for receiving, in-process, and finished product acceptance.
- Responsible for assuring First Article Inspections are completed for all new/modified articles
- Define, justify, acquire and implement inspection test equipment to meet specified needs.
- Provide input on product and process development to ensure manufacturability, reliability, and compliance with quality standards.
- Manage all activities related to Supplier Quality in accordance with policy, including supplier selection and evaluation, material qualification, inspection procedure development, supplier corrective action, supplier assessments, supplier performance reviews and supplier development.
Production Verification and Validation (V&V):
- In collaboration with R&D, review design verification and validation protocols and associated reports to ensure that products and production meet defined requirements and specifications.
- Work closely with R&D, manufacturing, processing, design quality and other teams to ensure that V&V activities are conducted in compliance with regulatory requirements.
- Review analytical methods, processes, and equipment to ensure that testing methods are accurate, reliable, and suitable for their intended purpose.
- Contribute to continuous improvement efforts by identifying areas for enhancing testing processes, methodologies, and tools.
- Review and analyze V&V data to ensure that products are safe, effective, and meet customer and regulatory expectations.
Sustaining Engineering:
- Provide quality engineering support for sustaining engineering activities, including product changes, process improvements, and design modifications.
- Ensure that changes to existing products are evaluated for impact on product quality and compliance, and that appropriate change controls are implemented.
- Support post-market activities, including complaint investigation, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
Risk Management:
- Ensure that risk management activities are 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 production activities, and report findings to management.
Regulatory Compliance and Audits:
- Support regulatory inspections and external audits related to production 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 – Engineering or similar technical/science degree
- TEN (10) years – Quality engineering within the medical device, tissue, biologics, pharmaceutical, or combination product industry, with a focus on design quality
- TEN (10) years – Design control process, V&V activities, risk management, corrective and preventative action investigation and root cause analysis, process flow charts, FMEAs, PFMAs, purchasing controls and control plans
- TEN (10) years – Management/Leadership experience with direct reports (including departmental budgeting experience)
- 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
- Auditor Training by ASQ (American Society for Quality)
- Certified Quality Engineer (CQE)
These would be nice too (Knowledge Skills and 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 preventive action
- LEAN/Six Sigma: 8D method of problem resolution. Quality Issues correction and prevent recurrence. Knowledge and experience in 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 interdependencies 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 work at LifeNet Health?
We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You will not find another company with a culture as strong as ours.
- 403(b) and Profit-Sharing Plan
- Affordable medical, dental, and vision coverage
- Corporate sponsored events for employees
- Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
- 18 vacation days
- 9 sick days
- 7 paid holidays
- Tuition reimbursement
- Personal career, skill, and leadership development opportunities
- Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)
- Employee Assistance Program (EAP) for employees and members of their household
- Dedicated and passionate co-worker
Salary: $152,547- $203,396/annually*
The pay rate for the successful candidate will depend on geographic location and the candidate's qualifications and prior relevant experience. *Actual compensation may be higher based on the successful candidate's knowledge and relevant experience.
This position is eligible for an annual bonus once eligibility criteria are met.
All benefits are subject to eligibility requirements and LifeNet Health reserves the right to modify or change these benefits programs at any time, with or without notice, unless otherwise required by law. Further, nothing in this posting is intended to alter the at will relationship of a successful candidate and this posting does not constitute a specific promise.
LifeNet Health is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
