Quality Assurance Inspector (Exp in First Article Inspection) Entry Level

MillenniumSoft Inc; San Jose (CA); On-site; USD 28,000 - 34,000; Part time

Benefits offered by this job

Job summary

MillenniumSoft Inc is seeking a Quality Assurance Inspector (First Article Inspection) in San Jose, CA for a 6-month contract. The role focuses on visual and dimensional inspection of materials and products within the QA group, with emphasis on data entry, documentation accuracy, and adherence to SOPs.

The candidate should have 1–2 years of QA experience, familiarity with FAI, GMP/ISO 9000 standards, and strong attention to detail to ensure quality and compliance in a medical device context.

Qualifications

• 1-2 years of QA Inspector experience required or equivalent.
• Experience with First Article Inspection is required.
• Understanding of engineering change order processes.
• Good Manufacturing Practices (GMP) knowledge expected.
• Strong organizational and prioritization abilities.
• Detail oriented with ability to follow procedures precisely.

Responsibilities

• Perform visual and dimensional inspections per established criteria.
• Assess dimensional accuracy against drawings and specs with appropriate tools.
• Document review and data entry, ensure Good Documentation Practices.
• Record inspection results in SAP and communicate issues to engineers.
• Follow SOPs and contribute to continuous improvement.

Skills

Attention to detail

Communication skills

Problem solving

Multi-tasking

Organizational skills

Team oriented

Adaptable / Collaborative

GMP knowledge

Education

High School Diploma

Tools

SAP

Minitab

Blue Mountain Regulatory Management

Microsoft Office

Job description

Position : Quality Assurance Inspector (Exp in First Article Inspection)

Location : San Jose, CA

Duration : 6 Months contract

Total Hours/week : 40.00

pay rate-$20-25/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 Or OPT EAD )

M-F 7:00 AM- 3:30 PM

3 Must Haves On The Resume

• Performed visual and dimensional inspection of raw materials, chassis, assemblies, packaging materials (labels, software, product inserts, optics, etc.) or finished products
• 1-2 years’ experience working as Quality Assurance Inspector (or equivalent)
• Experienced in First Article Inspection

Job Description

• This position will function within the Quality Assurance group.
• Quality Assurance strives to live client values as part of an action-oriented team focusing on customer requirements and process effectiveness through continuous learning, influencing of others, and dedication to achieving the highest quality results.
• Conducts visual and dimensional inspections, documentation review, & data entry.
• Reports quality failures encountered during inspection process verbally & in writing per the Quality Notification Reporting procedure and assists in determining corrective action to prevent reoccurrence of those errors.
• Is expected to use training, experience, basic knowledge of quality control concepts, practices, and procedures.
• Works under general supervision.
• Quality Assurance strives to live client values as part of an action-oriented team focusing on customer requirements and process effectiveness through continuous learning, influencing of others, and dedication to achieving the highest quality results.
• The QA inspector performs all activities with extreme care.
• The daily tasks performed by this position are critical to the assurance of quality produced product.
• Works effectively in a team environment and emphasized healthy customer relations.
• Responsible for ensuring that procedures & processes are followed.

Duties And Responsibilities

• Perform visual and dimensional inspection of raw materials, chassis, assemblies, packaging materials (labels, software, product inserts, optics, etc.) or finished products according to established criteria.
• Assess the dimensional accuracy of a physical part compared to engineering drawing/material specifications using the appropriate test & measuring tools.
• Conduct a thorough documentation review, ensuring that all recorded information are 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 BDIS 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.

Minimum Qualifications, Knowledge And Skills

• Experience in performing the duties/responsibilities described above.
• Experience in First Article Inspection
• Understands the engineering change order process
• Have a very good understanding of Good Manufacturing Practices.
• Good organizational and prioritization skills
• Ability to multi-task
• Must possess good problem-solving skills
• Must have a strong attention to detail & ability to follow procedures, and good oral and written communication skills.
• Must be familiar with mathematical calculations
• Computer literate with basic knowledge or Microsoft Windows & Office, SAP, Blue Mountain Regulatory Management Software, 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 (or equivalent)