Senior Quality Engineer

Location:

Virginia Beach, VA (Concert Dr.)

Department:
Quality Engineering

Job Type: Full-Time

Clinical Status:
Clinical

Shift: Mon-Fri 8:15AM-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 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…