Quality Engineer II - San Diego, CA

Location: San Diego, CA - Onsite

Schedule: Standard Office Hours

Duration: 3- Month Contract

Pay range: $40.00 - $44.00 per hour


This Quality Engineering position supports manufacturing and product quality activities within the Manufacturing/Operations (Mfg/Ops) Quality organization. The role focuses on sustaining manufacturing, continuous improvement, capacity expansion, and process/product validation. It involves cross-functional collaboration and application of regulatory standards (21 CFR 820, ISO 13485, etc.) to ensure product and process quality in a regulated environment.

Responsibilities

• Support product lifecycle quality engineering.
• Assist manufacturing with validation planning and transfer.
• Manage non-conformance and CAPA processes.
• Participate in technical discussions and risk-based decisions.
• Review equipment onboarding, calibration, and maintenance for GMP compliance.
• Review and ensure compliance of change control documentation.
• Identify and close compliance gaps efficiently and effectively.
• Use risk-based approaches for issue resolution.
• Ensure manufacturing processes comply with FDA/ISO requirements.
• Analyze and report quality data; develop data-driven recommendations.
• Provide updates and escalate issues as needed.
• Collaborate with cross-functional teams across multiple sites.
• Perform other assigned quality-related duties.
  

Desired Background

• Education : Bachelor's degree in an engineering or scientific field.
• Experience :
  • 2-4 years in quality assurance within a regulated industry.
  • In-vitro diagnostic manufacturing experience preferred.
  • Experience with quality systems (CAPA, NC, Change Management), PLM, ERP, MES tools.
  • Familiarity with nanoimprint lithography/surface activation chemistry is a plus.
• Skills :
  • Strong communication, problem-solving, and organizational skills.
  • Collaboration with cross-functional and global teams.
  • Ability to manage change and make compliance/business trade-off decisions.
  • Proficient in data analysis and quality improvement methodologies.
  • Knowledge of applicable regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD, CMDR).

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