Senior Quality Manager

Hello,

I hope you're doing well.

My name is Soundarya , 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 View email address on us.fitly.work

Job Title: Sr. Quality Engineer



Location: Hayward, CA Work Arrangement: Onsite
Experience Level: 5-6 years



Pay rate: $55-$58/hr on W2

Job Summary

We are looking for a Sr. Quality Engineer with experience in medical device quality, process validation, risk management, and computer system validation (CSV). The engineer will support manufacturing processes, product quality, regulatory compliance, and continuous improvement.

Key Responsibilities

• Support quality engineering and manufacturing processes from raw materials through finished products.
• Perform and support process validation and equipment/software validation activities.
• Execute validation protocols including DQ, IQ, OQ, PQ, and TMV.
• Develop and maintain risk management documentation for products, processes, and software.
• Perform root cause analysis, NCR, CAPA, and investigation of quality issues.
• Analyze process/product data and identify trends or potential quality issues.
• Support Computer System Validation (CSV), data integrity, and software change-control assessments.
• Evaluate impacts related to software, hardware, cybersecurity, and data integrity.
• Develop/review quality procedures and validation documentation in accordance with cGDP/GMP requirements.
• Work with Manufacturing and Project Engineering to implement process improvements and transition projects into production.
• Provide guidance on CSV, SDLC, data integrity, and cybersecurity best practices.

Required Qualifications

• 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 CSV/software validation and data integrity.
• Experience with NCR, CAPA, root cause analysis, and continuous improvement.
• Strong technical documentation and communication skills.

Preferred

• Lean/Six Sigma Green Belt or higher.
• Experience with regulated medical device/GxP environments.
• Experience with software validation, SDLC, and cybersecurity assessments.

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.

Thanks & Regards,
Soundarya
Technical Recruiter
Intellectt Inc


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