Quality Engineer

Responsibilities

• Design and document validation and verification for equipment, methods, material, and instrumentation
• Conduct ongoing monitoring and trending of quality and manufacturing data to identify emerging issues
• Lead root cause analysis and investigate CAPAs, complaints, and Non-Conformance Reports (NCRs)
• Participate in the Validation Program, including reviewing and approving protocols and reports
• Support the Material Review Board (MRB) for product review, control, and disposition
• Represent Quality Assurance in product development activities, including design reviews and risk management
• Assist in developing, reviewing, and improving procedures related to product quality
• Support internal and external audits to ensure continuous compliance

Requirements

• Bachelor’s degree in science, engineering, or veterinary fields
• Minimum of 3 years of experience in an FDA-regulated environment (medical device or in-vitro diagnostics preferred)
• Demonstrated knowledge of ISO 9001, ISO 13485, and ISO 14971 standards
• Proficiency in statistical techniques and data-driven problem-solving
• Strong technical writing and verbal communication skills
• Ability to work onsite in Union City, CA

Preferred Qualifications

• ASQ CQE or CQA certification
• Advanced degree (MS) in Science or Engineering
• Experience with lyophilization processes

Benefits

• Comprehensive healthcare and insurance benefits starting on day one
• 401K plan with company match and profit-sharing contributions
• Four weeks of vacation
• Short-term incentive compensation eligibility

About the Company

Zoetis is a Fortune 500 company and the world leader in animal health. Our purpose is to nurture our world and humankind by advancing care for animals through the discovery, development, and manufacture of vaccines, medicines, and diagnostics for companion animals and livestock.