Senior Quality Engineer - Medical Devices, NPI & Risk Lead

ASP Global; Austell (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

ASP Global is seeking a Senior Quality Engineer to lead risk management, support NPIs, and sustain engineering for Class I/II medical devices in the US. The role emphasizes ISO 13485, ISO 14971, design control, validations, and MDR documentation experience.

You will drive risk management files, cross-functional risk assessments, and CAPA investigations while mentoring teams and ensuring regulatory compliance.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related technical discipline.
• 5+ years of experience in quality engineering, product development, or manufacturing with the medical device industry.
• Experience leading risk management and design control activities.
• Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Familiarity with Class I medical devices and U.S. market requirements.
• Excellent communication, problem-solving, and organizational skills.
• Master’s degree or ASQ CQE/CQA preferred.

Responsibilities

• Own the creation, maintenance, and continuous improvement of Risk Management Files per ISO 14971.
• Facilitate cross-functional risk assessments throughout the product lifecycle.
• Partner with R&D to ensure quality is built into the design and development of new products.
• Provide quality engineering support for design changes, product updates, supplier diversification, and post-market surveillance.
• Provide process and test method validation expertise to suppliers and internal teams.
• Ensure compliance with ISO 13485, FDA QSR, and internal quality system requirements.
• Support internal and external audits.
• Lead or support CAPA and nonconformances investigations.
• Mentor and provide technical guidance across teams.
• Foster a culture of quality, continuous improvement, and cross-functional collaboration.

Skills

Risk management

Design control

Analytical skills

Mentoring

Cross-functional

Statistics

Education

Bachelor's degree in engineering or life sciences

Master's degree or ASQ CQE/CQA preferred

Tools

CAPA process

Job description

ASP Global is seeking a Senior Quality Engineer to lead risk management, support NPIs, and sustain engineering for Class I/II medical devices in the US. The role emphasizes ISO 13485, ISO 14971, design control, validations, and MDR documentation experience.

You will drive risk management files, cross-functional risk assessments, and CAPA investigations while mentoring teams and ensuring regulatory compliance.