Quality Systems Engineer: CAPA & Regulatory Compliance

THINK Surgical; Fremont (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

THINK Surgical is seeking a Quality System Engineer in Fremont, CA, responsible for supporting the Quality Management System (QMS). You will ensure QMS processes align with regulatory standards, maintain procedures, and support audits. The ideal candidate has a Bachelor’s degree in engineering or science, 3–6 years in Quality Assurance within the medical device sector, and strong skills in CAPA and compliance. This role is crucial to maintaining product quality and patient safety.

Qualifications

• 3–6 years of experience in Quality Assurance in the medical device field.
• Working knowledge of FDA 21 CFR Part 820/QMSR and ISO 13485.
• Strong experience with CAPA, complaints, nonconformance, and/or audits.

Responsibilities

• Support the implementation of core QMS processes.
• Ensure compliance with FDA and ISO standards.
• Perform and support investigations, including root cause analysis.

Skills

Quality Assurance

Regulatory Compliance

Problem Solving

Analytical Skills

Education

Bachelor’s degree in engineering, science or related discipline

Tools

eQMS systems (e.g., Propel, MasterControl, Compliance Quest, Arena)

Job description

THINK Surgical is seeking a Quality System Engineer in Fremont, CA, responsible for supporting the Quality Management System (QMS). You will ensure QMS processes align with regulatory standards, maintain procedures, and support audits. The ideal candidate has a Bachelor’s degree in engineering or science, 3–6 years in Quality Assurance within the medical device sector, and strong skills in CAPA and compliance. This role is crucial to maintaining product quality and patient safety.