Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Supporting manufacturing operations and production lines for medical devices with an accent on process control, inspection systems, and quality improvements. Focus on leading root cause investigations, managing CAPAs, and ensuring compliance with FDA QSR and ISO 13485 standards in a high-volume production environment.

Location: On-site in Alameda, CA

Salary: $125,000–$175,000

Company

hirify.global is a global healthcare company focused on innovative therapies for patients with neurovascular and peripheral vascular conditions.

What you will do

• Provide quality engineering support for assigned products and production lines.
• Lead complex root cause investigations using structured problem-solving tools like 5 Why, Fishbone, and DOE.
• Champion and improve inspection strategies, including destructive testing and sampling plans.
• Execute quality system activities such as NCRs, MRB, and CAPAs.
• Conduct and maintain pFMEAs to ensure risks are mitigated through appropriate controls.
• Collaborate with Manufacturing, Production, and Industrial Engineering teams to ensure quality is built into every stage.

Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, or Chemical preferred).
• 5+ years of experience in Quality or Manufacturing Engineering within the medical device industry.
• Working knowledge of FDA QSR and ISO 13485 in a manufacturing environment.
• Experience supporting manufacturing operations, process development, or NPI.
• Strong data analysis, problem-solving, and decision-making skills.
• Must be able to work on-site in Alameda, CA.

Nice to have

• CQE certification or related training.
• Experience with Measurement System Analysis (MSA) and Six Sigma Black Belt projects.
• Background in high-volume manufacturing and early commercial yield ramp.
• Experience managing projects or coordinating cross-functional activities.

Culture & Benefits

• Dynamic work environment involving office, laboratory, and cleanroom settings.
• Opportunity to work on life-saving medical device technology.
• Collaborative team culture across multiple engineering disciplines.
• Professional development and continuous improvement focus.