Senior QA Engineer - Medical Devices & Compliance

NIHON KOHDEN OrangeMed; Santa Ana (CA); On-site; USD 85,000 - 123,000; Full time

Job summary

NIHON KOHDEN OrangeMed is seeking a Quality Assurance Engineer III to support and improve product quality, manufacturing processes, and Quality Management System compliance in a regulated medical device environment.

This role provides advanced quality engineering support for new product development, sustaining engineering, supplier quality, and manufacturing operations, serving as a technical resource and leading complex quality initiatives.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• 3–5 years of quality engineering experience in a regulated environment (medical device preferred).
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Experience with NCR/NMR, complaint investigations, validations, supplier quality, and audits.
• Experience supporting product development and design control activities preferred.
• Knowledge of statistical analysis, sampling plans, SPC, and quality data trending.

Responsibilities

• Ensure quality system processes are in compliance with US-FDA, MDD/MDR, ISO 13485 and other country-specific medical device regulations.
• Provide advanced quality engineering support for manufacturing operations to meet specifications, regulatory requirements, and quality standards.
• Establish and maintain the non-conforming material system with technical justification and risk assessment.
• Participate in material review board meetings for nonconforming materials and root cause analyses.
• Collect and trend key quality indicators for management review.
• Develop quality plans for new processes or process improvements.
• Support manufacturing in-process validation activities and change control.
• Facilitate receiving inspection, first article inspection, and calibration activities.
• Support supplier management including supplier approvals, audits, and corrective actions.
• Lead corrective/preventive action systems and perform root cause analysis with effectiveness checks.
• Conduct internal quality audits to ensure compliance with Quality System and regulations.

Skills

Analytical skills

Problem-solving

Communication

Cross-functional collaboration

MS Office

Quality management software

Education

Bachelor's degree in engineering or biological sciences

Tools

Quality management software

Job description

NIHON KOHDEN OrangeMed is seeking a Quality Assurance Engineer III to support and improve product quality, manufacturing processes, and Quality Management System compliance in a regulated medical device environment.

This role provides advanced quality engineering support for new product development, sustaining engineering, supplier quality, and manufacturing operations, serving as a technical resource and leading complex quality initiatives.