Quality Engineer

Prospect Blue is seeking an experienced Quality Engineer to join our manufacturing team in Newport News, VA. This job is on-site!

The Quality Engineer will be responsible for ensuring that our products meet rigorous quality standards in compliance with applicable regulatory requirements, including FDA regulations and ISO standards relevant to medical device manufacturing. This role plays a critical part in driving continuous improvement initiatives, supporting product development, and maintaining our quality management system.

• Develop, implement, and maintain quality control processes and procedures in alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory standards.
• Perform incoming, in-process, and final inspection of components and finished products to ensure conformance to specifications.
• Investigate non-conformances, customer complaints, and field returns using structured problem-solving methodologies such as 8D, CAPA, and root cause analysis.
• Author and manage Corrective and Preventive Action (CAPA) documentation and ensure timely closure of quality issues.
• Support process validation activities including IQ, OQ, and PQ protocols for manufacturing equipment and processes.
• Collaborate with engineering, production, and supply chain teams to drive design for manufacturability and quality improvements.
• Maintain and update quality documentation including SOPs, work instructions, inspection plans, and control plans.
• Participate in internal and external audits, including supplier audits and regulatory inspections, and assist in the preparation of audit-ready documentation.
• Analyze quality data and metrics to identify trends and drive proactive quality improvements.
• Support new product introduction (NPI) activities through the development of inspection criteria and quality plans.
• Perform measurement system analysis (MSA) including gauge R&R studies to ensure accuracy and repeatability of inspection methods.
• Champion a culture of quality throughout the organization by mentoring production staff and promoting quality best practices.

• Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related field) or equivalent experience.
• Minimum of 3–5 years of quality engineering experience in a regulated manufacturing environment, preferably medical devices.
• Demonstrated knowledge of FDA 21 CFR Part 820, ISO 13485, and/or ISO 9001 quality management systems.
• Proficiency in root cause analysis tools such as Fishbone diagrams, 5-Why, FMEA, and control plans.
• Experience with statistical process control (SPC), Cpk analysis, and data-driven quality methods.
• Strong technical writing skills with the ability to create and revise controlled documents.
• Familiarity with ERP and quality management software systems.
• Excellent communication and cross-functional collaboration skills.

• ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt certification.
• Experience with radiation shielding products or personal protective equipment (PPE) manufacturing.
• Familiarity with Solid Works or similar CAD software for engineering drawing review.
• Experience supporting FDA inspections or Notified Body audits.
• Working knowledge of risk management processes per ISO 14971.