LifeNet Health · 16 hours ago
Senior Quality Engineer (10135-2025505)
Virginia Beach, VA
Full-time
Onsite
Senior Level, Lead/Staff
$100K/yr - $134K/yr
8+ years expLifeNet Health is the largest nonprofit organ procurement organization and tissue processor in the United States, dedicated to saving lives and restoring health. The Senior Quality Engineer will lead quality and compliance for new product development and sustaining engineering projects in the medical device industry, ensuring alignment with regulatory and business objectives.
CharityHealth CareMedicalMedical DeviceNon Profit
Responsibilities
Lead Engineer for ensuring compliance with regulatory requirements and company standards in all production activities
Serve as the lead Quality Engineering authority with Procurement, Receiving, and Business Units to meet component requirements and improve quality control inspection methods
Serve as the lead Quality Engineering authority for management of NCRs, CAPAs, Deviations, and other Quality System elements
Manage nonconforming materials and ensure proper documentation and communication for resolution
Develop and implement quality control inspection plans and ensure First Article Inspections for new or modified articles are completed
Quality Engineering authority for supplier quality activities, including selection, evaluation, and performance reviews, while providing input on product and process development for manufacturability and compliance
Serve as the lead Quality Engineering authority across the product development lifecycle, including design development, reviews, and post market activities and driving quality strategy in cross-functional team, from concept through design transfer and commercialization
Ensure that all design control activities are conducted in compliance with regulatory requirements and company standards
Quality Engineering authority for design inputs, design outputs, design verification and validation plans/reports, and design transfer activities
Quality Engineering authority for design reviews, ensuring that design risks are identified, assessed, and mitigated appropriately
Quality Engineering authority on product and process development to ensure manufacturability, reliability, and compliance with quality standards
Ensures design verification and validation protocols and associated reports for products and production meet defined quality requirements and specifications
Oversees R&D, manufacturing, processing, design quality and other teams to ensure that V&V activities are conducted in compliance with regulatory requirements
Quality Engineering authority for analytical methods, processes, and equipment to ensure that testing methods are accurate, reliable, and suitable for their intended purpose
Lead and support continuous improvement efforts including enhancing testing processes, methodologies, and tools
Quality Engineering authority for verification and validation (V&V) data to ensure that products are safe, effective, and meet customer and regulatory expectations
Provide quality engineering leadership for sustaining engineering activities, including product changes, process improvements, and design modifications
Oversee and approve quality risk assessments for product and process changes; ensure product quality and compliance with appropriate change controls and implementation
Drives strategic initiatives to enhance quality system framework
Support post-market activities, including complaint investigation, root cause analysis, and implementation of corrective and preventive actions (CAPAs)
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
Leads and facilitates risk assessment for product and process design or changes to support the Process Failure Mode and Effects Analysis (PFMEA) and other risk assessment tools to identify potential risks and develop mitigation strategies
Leads identification and implementation 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
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
Qualification
Required
Bachelor's Degree – Engineering or similar technical/science degree
8 Years – Production/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
2 Years – Experience in medical device or similar regulated industry
Auditor Training - Current or obtained within 6 months of employment (BSI, AIAG, etc.)
Preferred
Master's Degree – Engineering or similar technical/science degree
Auditor Training by ASQ – American Society for Quality
Certified Quality Engineer (CQE)
Lean six Sigma Green Belt or higher
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 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 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
Benefits
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
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
Company
LifeNet Health
LifeNet Health is a charitable organization in the field of regenerative medicine.
1001-5000 employees
H1B Sponsorship
LifeNet Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Phil Jones
Chief Financial Officer
Recent News
Venture Capital
2025-12-16
Company data provided by crunchbase