Sr Quality Engineer

My name is Rudra, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for Sr. Quality Engineer based in Hayward, CA with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at <

Job Title: Sr. Quality Engineer
Location: Hayward, CA
Work Arrangement: Onsite
Experience Level: 3 5 Years
Pay rate: $55-$58/hr on W2

Skills: Process Validation, Medical Device Risk Management, CSV, CAPA/Root Cause Analysis, and Data Integrity/GxP

Job Description:

We are looking for a Sr. Quality Engineer to support manufacturing and quality operations for medical device products. The engineer will ensure products and processes meet quality, regulatory, and company requirements.

• Support process validation activities including DQ, IQ, OQ, PQ, and TMV.

• Manage risk assessment and risk management documentation.

• Perform root cause analysis, NCR, and CAPA activities.

• Analyze quality and manufacturing data to identify trends and improve processes.

• Support Computer System Validation (CSV) and software validation activities.

• Ensure data integrity and GxP/cGMP compliance.

• Review and support change controls and validation documentation.

• Work with Manufacturing and Project Engineering teams on process improvements.

• Maintain quality documentation and support audits and regulatory requirements.

• Provide guidance on quality, validation, data integrity, and cybersecurity practices.

• Bachelor's degree in Engineering or related field.

• 3 5+ years of Quality Engineering experience, preferably in medical devices.

• Strong experience with process validation and risk management.

• Knowledge of CAPA, NCR, root cause analysis, and quality systems.

• Experience with CSV/software validation and data integrity is preferred.

• Strong communication, documentation, and problem-solving skills.

• Lean/Six Sigma Green Belt is a plus.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

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