Quality Assurance Technician - Urgent Need

MillenniumSoft Inc; San Jose (CA); On-site; USD 57,308,000 - 85,962,000; Full time

Job summary

The Medical Device Company in San Jose, CA seeks an Entry Level Quality Assurance Technician for a 6-month contract (W2). You will inspect materials and assemblies, record results in SAP, and ensure documentation meets Good Documentation Practices.

Responsibilities include following SOPs, prioritizing workload, and collaborating with Engineers, Purchasing, Suppliers, and Planners while adhering to EH&S policies.

Qualifications

• Experience in First Article Inspection and GMP/ISO 9000 environments.
• Strong mathematics skills and ability to read engineering drawings.
• Good Documentation Practices and SAP data entry.
• Experience with GMP/ISO 9000 environments or regulatory workflows.

Responsibilities

• Perform visual and dimensional inspection of materials and finished products per specifications.
• Assess dimensional accuracy against drawings using test and measurement tools.
• Record inspection results in SAP and maintain complete documentation.
• Communicate issues to responsible engineers in writing and verbally.
• Follow SOPs, prioritize daily tasks, and support department goals.

Skills

First Article Inspection

Attention to detail

Read engineering drawings

Problem solving

Communication

Teamwork

Education

High School Diploma or equivalent

Tools

SAP

Minitab

Microsoft Office

Job description

Level of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Job Description

• 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 & measuring tools.
• Conduct a thorough documentation review, ensuring that all recorded information is complete and meets the requirement 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 the standard operating procedures (SOP).
• Prioritize/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, Supplier, Planners, Manufacturing Associates, etc.
• Adhere to client San Jose's Quality System requirements.
• Participate and contribute to continuous improvement activities.
• Monitor changes to applicable procedures and completes training in a timely manner.
• Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements.
• Participate as required in training on regulatory issues affecting own area of work. Brings 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. Participates in EH&S programs.
• Notifies supervisor of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment.

Position : Quality Assurance Technician

Location : San Jose, CA

Duration : 6 Months

Total Hours/week : 40.00

pay rate-$20-30/hr

1st Shift

Client: Medical Device Company

Job Category: Quality

Level of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Job Description

• 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 & measuring tools.
• Conduct a thorough documentation review, ensuring that all recorded information is complete and meets the requirement 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 the standard operating procedures (SOP).
• Prioritize/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, Supplier, Planners, Manufacturing Associates, etc.
• Adhere to client San Jose's Quality System requirements.
• Participate and contribute to continuous improvement activities.
• Monitor changes to applicable procedures and completes training in a timely manner.
• Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements.
• Participate as required in training on regulatory issues affecting own area of work. Brings 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. Participates in EH&S programs.
• Notifies supervisor of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment.

Duties And 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 & measuring tools.
• Conduct a thorough documentation review, ensuring that all recorded information is complete and meets the requirement 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 the standard operating procedures (SOP).
• Prioritize/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, Supplier, Planners, Manufacturing Associates, etc.
• Adhere to client San Jose's Quality System requirements.
• Participate and contribute to continuous improvement activities.
• Monitor changes to applicable procedures and completes training in a timely manner.
• Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements.
• Participate as required in training on regulatory issues affecting own area of work. Brings 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. Participates in EH&S programs.
• Notifies supervisor of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment.

Knowledge and Skills

• Experience in performing the duties/responsibilities described above.
• Experience in First Article Inspection
• Strong mathematics skills
• Highly detail oriented
• Ability to read and interpret engineering drawings
• Have a very good understanding of Good Documentation Practices.
• Good organizational and prioritization skills
• Ability to multi-task
• Must possess good problem-solving skills
• Must be familiar with mathematical calculations
• Computer literate with basic knowledge or Microsoft Windows & Office, SAP, Minitab, etc.
• Adaptive, collaborative, agile,
• Proficient verbal & written communication skills
• Team-oriented with commitment to the success of the team and organizational goals to track and complete assignments.
• Experience working under GMP, or ISO 9000 environment

Education And Experience

• High School Diploma or equivalent.
• 1-2 years’ experience working as Quality Assurance Inspector in a GMP, FDA or ISO 9000 environment.

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