Quality Engineer I - Medical Devices, Risk & Compliance

LifeNet Health; Virginia Beach (VA); On-site; USD 75,841 - 101,121; Full time

Benefits offered by this job

Medical, Dental, Vision Coverage

Profit Sharing Plan

403(b) Retirement Plan

Paid Parental Leave

Flexible Work Program

Tuition reimbursement

Job summary

LifeNet Health in Virginia Beach seeks a Quality Engineer I to support product development and production lifecycles, ensuring quality compliance and continuous improvement. The role emphasizes cross-functional collaboration across design, manufacturing, and R&D to align with FDA/ISO requirements.

The position focuses on risk management, V&V, and design controls, with a mission-driven environment dedicated to patient outcomes and regulatory excellence.

Qualifications

• Bachelor’s Degree in Engineering is required.
• 2 years engineering experience or a Master’s degree qualifies.
• Experience in medical devices or regulated industry preferred.
• Strong communication and teamwork skills are essential.

Responsibilities

• Serve as the Quality Engineering authority across the product lifecycle.
• Ensure compliance with regulatory and quality system requirements (21 CFR 820, ISO 13485, ISO 14971).
• Provide leadership for design inputs/outputs, verification/validation, risk management, and design reviews.
• Support NCRs, CAPAs, deviations, change controls, and investigations with root-cause analysis.
• Develop inspection strategies, control plans, and First Article Inspection requirements.
• Partner with Procurement, Receiving, Manufacturing, and R&D on supplier quality.

Skills

Quality Engineering

Regulatory compliance

Risk management

Cross-functional teamwork

Design verification

Education

Bachelor’s Degree – Engineering

Master’s Degree or PhD – Engineering

Tools

MS Office

Job description

LifeNet Health in Virginia Beach seeks a Quality Engineer I to support product development and production lifecycles, ensuring quality compliance and continuous improvement. The role emphasizes cross-functional collaboration across design, manufacturing, and R&D to align with FDA/ISO requirements.

The position focuses on risk management, V&V, and design controls, with a mission-driven environment dedicated to patient outcomes and regulatory excellence.