Quality Assurance Technician (Must Have incoming , First Article Inspection, GMP, FDA Exp)

Location: San Jose, CA • Duration: 6 months • Schedule: 40 hours/week, 1st shift • Pay: $20–30/hr

Responsibilities

• Perform visual and dimensional/mechanical inspection of raw materials (machined parts, optics, chassis, assemblies) and finished products according to material specifications, engineering drawings, and work instructions.
• Assess dimensional accuracy of machined parts using appropriate inspection methodology and measuring tools.
• Conduct thorough documentation review to ensure completeness and compliance with Good Documentation Practices.
• Record inspection results accurately on applicable forms or electronically in SAP.
• Communicate issues verbally and in writing to responsible engineers.
• Document discrepancies found during inspection in accordance with the Quality Notification Reporting procedure.
• Ensure quality records are complete when saving/uploading to SAP.
• Follow standard operating procedures (SOP).
• Prioritize and coordinate daily workload assignments to ensure timely completion.
• Support and contribute to the attainment of department/business goals.
• Interact effectively with peers and internal/external customers (Engineers, Purchasing, Suppliers, Planners, Manufacturing Associates).
• Adhere to BDB San Jose’s Quality System requirements.
• Participate and contribute to continuous improvement activities.
• Monitor changes to applicable procedures and complete training in a timely manner.
• Keep abreast of compliance requirements in own area of work and comply with those requirements.
• Participate in training on regulatory issues affecting own area of work; escalate compliance questions/issues to management.
• Follow BDIS Environmental, Health and Safety (EH&S) policies and procedures.
• Take responsibility for safety in immediate work area; participate in EH&S programs and notify supervisor of hazardous conditions or unsafe work practices.

Requirements

• High School Diploma or equivalent.
• 1–2 years minimum experience in incoming inspection, First Article Inspection, or dimensional inspection of machined parts.
• 1-year minimum experience working in a GMP, FDA, or ISO 9000 environment.
• Experience in performing the duties/responsibilities described above.
• Strong mathematics skills and ability to read and interpret engineering drawings.
• Highly detail-oriented with a strong understanding of Good Documentation Practices.
• Good organizational, prioritization, and problem-solving skills.
• Ability to multi-task and work collaboratively in a team environment.
• Computer literate with basic knowledge of Microsoft Windows & Office, SAP, and Minitab.
• Proficient verbal and written communication skills.
• Adaptive, agile, and committed to organizational goals.