Location: Virginia Beach, VA (Concert Dr.)
Department: Quality Engineering
Job Type: Full-Time
Clinical Status: Clinical
Shift: Mon-Fri 8:15AM-5PM
Travel: 40%
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 Senior Quality Engineer is responsible for leading the quality and compliance elements of both new product development and sustaining engineering projects in the medical device/biologics/tissue combination product industry. This role involves leading cross-functional initiatives and serving as the primary Quality Engineering representative in design and production efforts, ensuring strategic alignment with regulatory and business objectives while 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 / Design Core Function
Assigned to either Production or Design core functions within the Quality Engineering Department.
Production:
- 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.
-OR-
Design:
- 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.
Verification and Validation (V&V)
- 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.
Sustaining Engineering
- 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).
- Subject Matter Expertise: Provides Quality Engineering subject matter expertise for quality management; product, Process, and service design; product and process controls, supplier quality, risk management, continuous improvement, and compliance
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.
- 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.
Continuous Improvement
- 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.
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.
What you'll bring (Minimum Requirements):
- 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
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 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
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: $100,306 - $133,741/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.
