Quality Engineer II

Job Title: Quality Engineer II

Duration: 12 Months

Location: Santa Clara, CA 95054

Description

The Quality Engineer II is responsible for providing advanced quality engineering support across product development, sustaining engineering, and cross functional initiatives.

This role focuses on ensuring product and process compliance in accordance with FDA regulations, risk management standards, and internal quality system procedures.

Key Responsibilities

• Lead and execute quality engineering activities throughout product lifecycle, including design controls, risk management, and verification & validation planning.
• Author, review, and maintain high quality technical documentation, including protocols, reports, and engineering specifications.
• Facilitate and drive cross functional engineering review meetings to ensure alignment on quality and regulatory expectations.
• Apply 21 CFR 820 Quality System Regulation requirements to ensure compliance across design and manufacturing processes.
• Develop, maintain, and execute DFMEA/FMEA and risk management activities per ISO 14971 and internal procedures.
• Support Engineering Change Orders (ECO/ECR), ensuring changes meet quality and regulatory standards.
• Develop V&V strategies and participate in execution and review of studies ensuring robust evidence for product performance and safety.
• Collaborate with Operations, R&D, and Manufacturing teams to address quality issues and continuous improvement opportunities.
• Provide support for root cause investigations and corrective/preventive actions (CAPA) as needed.
  
  

Top Required Skills & Qualifications

• Technical Writing – Ability to produce clear, structured, and compliant technical documentation.
• Project Management Skills – Capable of organizing and driving technical reviews and cross functional meetings.
• Regulatory Knowledge – Strong familiarity with 21 CFR 820 (FDA Quality System Regulation).
• Risk Management Expertise – Experience with DFMEA, FMEA, and ISO 14971 risk management activities.
• Engineering Change Control – Hands-on experience with ECO/ECR processes in engineering or manufacturing environments.
• Verification & Validation (V&V) Strategy – Experience developing or executing V&V plans.
  
  

Preferred Qualifications

• Experience in Operations or Sustaining Engineering support.
• Experience writing and processing Nonconformance Reports (NCRs).
• Experience performing Process Change Impact Assessments.
• Prior experience in medical devices or other regulated industries (ISO 13485 preferred).
  
  

Years Of Experience

• 5–7 years of relevant engineering experience (appropriate for a QE III level).
• Minimum 3 years may be considered with strong competencies and industry experience.
  
  

Required Education

• Bachelor’s degree in engineering required.
• Preferred fields: Biomedical Engineering, Manufacturing Engineering, Chemical Engineering, or related technical discipline.