Job Details

Senior Quality Engineer

Location: Newport News, Virginia
Schedule: Onsite, Monday–Friday, 8:00 AM – 5:00 PM EST
Salary: $112,000 – $122,000

We are hiring on behalf of an established medical device manufacturer for a senior quality engineer position based onsite in Newport News, VA. This is a full-time, hands-on role for a professional with experience in ISO 13485, QMS, and medical devices, specifically including Class I and Class III devices.

Job Summary

The Senior Quality Engineer will lead efforts to maintain and enhance the company's Quality Management System (QMS), ensure regulatory compliance, and support continuous quality improvement in manufacturing and product development. This position plays a key role in supporting products across Class I and Class III medical devices, contributing to patient safety and regulatory excellence.

Key Responsibilities

• Evaluate and improve QMS processes to increase efficiency and regulatory compliance.
• Collaborate with cross-functional teams including Manufacturing, QA, R&D, and Engineering.
• Review and approve design documentation, test procedures, and quality-related manuals.
• Ensure product quality meets regulatory and internal standards for Class I and Class III medical devices.
• Provide quality support during product development and manufacturing processes.
• Investigate nonconformities (NCRs, MRB), deviations (DAs), and supplier complaints (SCARs), including root-cause analysis and implementation of corrective actions.
• Analyze data to identify trends in product defects and initiate preventive measures.
• Maintain document control systems, including initiation and closure of change orders.
• Assist in maintaining and updating Risk Management Plans and Files.
• Serve as backup for incoming inspection processes.
• Support internal and external regulatory audits.
• Assist in initiating and closing Corrective and Preventive Actions (CAPAs).
• Perform other quality-related duties as assigned.

Required Skills and Abilities

• Familiarity with Class I and Class III medical device requirements.
• Project management experience is a plus.
• Excellent communication and technical writing skills.
• Strong organizational skills and attention to detail.
• Proficiency with Microsoft Office tools.
• Ability to interpret and apply statistical data to quality issues.
• Understanding of manufacturing and inspection processes.

Education and Experience

• Bachelor's degree in Engineering, Science, or a related field.
• CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) .
• Minimum of 3 years of hands-on experience with ISO 13485-certified Quality Management Systems.
• Experience in an FDA-regulated environment, specifically with Class I and Class III medical devices is a PLUS.