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Hiring _ Sr. Quality Technician _ Santa Clara, CA

TekOne IT Services Pvt. Ltd.
Santa Clara, CA Contractor
POSTED ON 12/14/2024
AVAILABLE BEFORE 2/10/2025
Role: Sr. Quality Technician

Location: Santa Clara, CA - 95054-2807

Duration: 12 Months

Key Responsibilities

  • Conduct functional testing and inspections on components, subassemblies, and finished products.
  • Measure component dimensions and record inspection and test data according to specified procedures.
  • Document non-conformance reports and recommend process improvements.
  • Perform audits of manufacturing records and ensure compliance with GMP and SOPs.
  • Support final review of Device History Records (DHR) and Lot History Records (LHR).
  • Assist in the documentation process, ensuring clarity and accuracy.
  • Maintain quality records and support equipment control, calibration, and preventive maintenance activities.
  • Provide quality support for product development, improvement projects, and key processes.
  • Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  • Keep up-to-date with industry regulations and standards, including FDA and ISO 13485.
  • Required Qualifications:
  • High school diploma or equivalent qualification.
  • 4 years of experience in manufacturing or a related field.
  • Proficiency in MS Office, Excel, and quality control standards.
  • Strong knowledge of FDA regulations, ISO 13485, and other applicable regulatory requirements.
  • Excellent communication skills, attention to detail, and the ability to work collaboratively.
  • Strong organizational skills and the ability to multitask effectively.
  • Preferred Qualifications:
  • 3 years of experience in the medical device industry.

Kalyan Kumar | Senior Recruiter

Intellectt INC

732 -769-3893 | EXT- 274

kalyan@intellectt.com intellectt.com/

517 Route 1 South, Suite 1115 Iselin, NJ 08830,

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