Yoh, A Day & Zimmermann Company · 11 hours ago
C4652a-US1 - Mfg/Ops Quality Engineer 2 (Contractor) - US1
San Diego, CA
Contract
Onsite
Entry, Mid Level
$35/hr - $44/hr
2+ years expYoh is hiring a Manufacturing/Operations Quality Engineer 2 for one of their biotechnology clients in the San Diego, CA area. This position is responsible for manufacturing and product Quality activities, supporting day-to-day sustaining activities in a manufacturing environment and ensuring compliance with FDA and ISO requirements.
Bookkeeping and PayrollConsultingStaffing Agency
Responsibilities
Provide ongoing quality engineering support throughout the product life cycle
Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements
Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions
Support process risk management activities and ensure quality and completeness of validation packages, and change orders
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Review verification and validation reports and identify gaps for GMP compliance
Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
Coordinate issue resolution using a risk-based approach
Ensure manufacturing processes and validation programs meet requirements of FDA and ISO
Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analysis
Collaborate with counterparts and cross-functional teams at other client sites
Other activities as assigned
Qualification
Required
2-5+ years of related experience and a Bachelor's degree in engineering/science
Familiarity with GMP, working in a regulated environment, and Nonconformance Reports (NCR)
Knowledge of equipment lifecycle (including onboarding, validation, maintenance)
Strong communication skills (written and oral)
Process risk/pFMEA experience
Experience with problem solving/root cause analysis tools
Benefits
Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
Health Savings Account (HSA) (for employees working 20+ hours per week)
Life & Disability Insurance (for employees working 20+ hours per week)
MetLife Voluntary Benefits
Employee Assistance Program (EAP)
401K Retirement Savings Plan
Direct Deposit & weekly epayroll
Referral Bonus Programs
Certification and training opportunities
Company
Yoh, A Day & Zimmermann Company
When progress demands experience, that’s where we come in.
1001-5000 employees
H1B Sponsorship
Yoh, A Day & Zimmermann Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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2025 (57)
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2020 (27)
Funding
Current Stage
Late StageLeadership Team
Peter Melomo
Vice President, Sales Strategy & Professional Consulting Services
Tom Enright
VP Recruiting - Specialty Practices
Recent News
Philadelphia Business Journal
2025-01-11
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