Quality Engineer

Seniority Level: Entry Level / Early Career

A leading medical device manufacturing organization in San Jose is seeking a Quality Engineer to support manufacturing quality, process improvement, and compliance initiatives within a regulated production environment.

This position plays a key role in ensuring product reliability, reducing non-conformances, and strengthening quality systems across operations. The role is ideal for recent engineering graduates or early-career professionals seeking hands‑on experience in a structured, quality‑driven manufacturing setting.

• Support investigation of production issues through structured root cause analysis.
• Assist in implementing corrective and preventive actions (CAPA).
• Monitor manufacturing performance metrics to identify trends in defects, scrap, and rework.
• Collaborate with production teams to improve process consistency and product reliability.
• Participate in continuous improvement initiatives focused on quality and efficiency.

• Assist in evaluating inspection methods and measurement systems.
• Support validation of fixtures, tools, and production equipment.
• Review engineering drawings, schematics, and GD&T documentation.
• Participate in risk assessments and verification activities.
• Ensure documentation aligns with internal quality standards and regulatory requirements.

• Maintain accurate quality records in accordance with company procedures.
• Support documentation updates for process changes and quality improvements.
• Assist with internal audits and compliance reviews.
• Ensure activities meet ISO and FDA quality system standards.
• Help track and resolve non‑conformance reports.

• Analyze process and quality data to identify improvement opportunities.
• Prepare summary reports for engineering and operations teams.
• Support financial and operational impact assessments related to quality issues.
• Assist in developing dashboards or tracking tools for quality performance.

• Work closely with manufacturing, engineering, and supply chain teams.
• Participate in cross‑functional problem‑solving discussions.
• Support mentoring and training efforts related to quality practices.
• Communicate findings clearly and professionally within technical teams.

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering field.
• Strong analytical and problem‑solving skills.
• Ability to interpret technical drawings and engineering documentation.
• Basic understanding of quality principles and manufacturing processes.
• Strong written and verbal communication skills.

• Exposure to regulated environments such as medical devices or aerospace.
• Familiarity with ISO 13485 or FDA Quality System Regulations.
• Knowledge of Lean, Six Sigma, SPC, or structured problem‑solving tools.
• Experience with validation, risk assessment, or CAPA processes.
• Internship or co‑op experience in manufacturing or quality engineering.

• Must be legally authorized to work in the United States (OPT accepted).
• Must be available to work fully on‑site in San Jose, CA.
• Must hold a completed Master’s degree in Engineering or related field in the US.