Senior Quality Engineer

Senior Quality Engineer

Location:

Virginia Beach, VA (Concert Dr.)

Department:
Quality Engineering

Job Type: Full-Time

Clinical Status:
Clinical

Shift: Mon-Fri8:15AM-5PM

Travel: 40%

Life Net Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.

Life Net 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. Life Net Health has over 1200 employees and has a growing global presence.

How you will contribute to Life Net Health’s success:

The Senior Quality Engineer is 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 / Design Core Function
Assigned to either Production or Design core functions within the Quality Engineering Department.

Production:

• Ensure compliance with regulatory requirements and company standards in all production activities.
• Collaborate with Procurement, Receiving, and Business Units to meet component requirements and improve quality control inspection methods.
• Review and coordinate approvals of NCRs, CAPAs, Deviations, and other Quality System inputs.
• 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.
• Oversee Supplier Quality activities, including selection, evaluation, and performance reviews, while providing input on product and process development for manufacturability and compliance.

-OR-

Design:

• Provide quality engineering support throughout the entire product development lifecycle, from concept through design transfer and commercialization.
• Ensure that all design control activities are conducted in compliance with regulatory requirements and company standards.
• Review and approve design inputs, design outputs, design verification and validation plans/reports, and design transfer activities.
• Participate in design reviews, ensuring that design risks are identified, assessed, and mitigated appropriately.
• Provide input on product and process development to ensure manufacturability, reliability, and compliance with quality standards.

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…