Quality Assurance Technician - Urgent Need

Location: San Jose, CA | Duration: 6 months | Hours: 40/week | Pay rate: $20–30/hr (1st shift) | Contract on W2 (US citizens or GC holders only)

About the role

Entry-level contract position with a medical-device company. The Quality Assurance Technician performs visual and dimensional inspections of raw materials, optics, chassis, assemblies, packaging materials, and finished products in accordance with material specifications and engineering drawings.

Responsibilities

• Perform visual and dimensional inspection of raw materials, optics, chassis, assemblies, packaging materials (labels, software, product inserts, optics, etc.) or finished products according to established criteria defined in the material specifications.
• Assess the dimensional accuracy of a physical part, comparing it to engineering drawing/material specification using the appropriate test and measuring tools.
• Conduct a thorough documentation review, ensuring that all recorded information is complete and meets the requirements of Good Documentation Practices.
• Clearly and accurately record the result of inspection on applicable forms or electronically in SAP.
• Communicate issues verbally and in writing to responsible engineers.
• Document discrepancies found during inspection process in accordance with the Quality Notification Reporting procedure.
• Ensure that 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 the department/business goals.
• Interact effectively with peers and internal and external customers—Engineers, Purchasing, Suppliers, Planners, Manufacturing Associates, etc.
• Adhere to the client’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 the basic requirements for compliance in own area of work and comply with those requirements.
• Participate as required in training on regulatory issues affecting own area of work; bring regulatory compliance questions/issues to the attention of management.
• Follow client Environmental, Health and Safety (EH&S) policies and procedures.
• Take responsibility for safety in immediate work area; participate in EH&S programs; notify supervisor of all observed hazardous conditions or unsafe work practices; may provide recommendations on maintaining the safety of the work environment.

Requirements

• High school diploma or equivalent.
• 1–2 years’ experience working as a Quality Assurance Inspector in a GMP, FDA, or ISO 9000 environment.
• Experience in performing the duties/responsibilities described above.
• Experience in First Article Inspection.
• Strong mathematics skills and ability to read and interpret engineering drawings.
• Very good understanding of Good Documentation Practices.
• Good organizational and prioritization skills; ability to multi-task.
• Good problem-solving skills.
• Computer literate with basic knowledge of Microsoft Windows & Office, SAP, Minitab, etc.
• Adaptive, collaborative, agile, and team-oriented with commitment to the success of the team and organizational goals.
• Proficient verbal and written communication skills.