Position: Quality Assurance Inspector
Location: San Jose, CA
Duration: 12+ Months
Total Hours/week: 40.00
Client: Medical Device Company
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
Job Summary
This position will function within the Quality Assurance group.
The Quality Assurance Inspector is expected to conduct inspection of components, assemblies, finished products, spare parts, repaired parts, repaired/refurbished products, etc., visually, or dimensionally using the applicable test & measuring equipment.
It is the QA Inspector's job to perform a thorough verification of documentation (quality records) for accuracy & completeness & records the result of inspection in writing or electronically in SAP database. Discrepancies found are communicated verbally & in writing per the Quality Notification Reporting procedure and assists engineering as needed in the root cause investigation.
The QA Inspector Is expected to use training, experience, basic knowledge of quality control concepts, practices, and procedures. Works under general supervision.
Quality Assurance strives to live BD 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
1. Perform documentation verification, visual & dimensional inspection of raw materials, returns from the field, repaired/refurbished finished products according to established acceptance criteria that is defined in material specifications, engineering drawing, OMS, Test Procedures, etc.
2. Assess the dimensional accuracy of machined parts using the appropriate inspection methodology & measuring tools.
3. Conduct a thorough documentation review, ensuring that all recorded information is complete and meets the requirement of Good Documentation Practices
4. Clearly and accurately record the result of inspection on applicable forms or electronically in SAP.
5. Communicate issues verbally and in writing to responsible engineers.
6. Document discrepancies found during inspection process in accordance with the Quality Notification Reporting procedure.
7. Ensure that quality records are complete when saving/uploading to SAP
8. Follow the standard operating procedures (SOP).
9. Ensures timely completion of daily work assignments.
10. Support and contribute to the attainment of the department/business goals.
11. Interact effectively with peers.
12. Adhere to BDB San Jose's Quality System requirements & BD Values.
13. Participate and contribute to continuous improvement activities.
14. Monitor changes to applicable procedures and completes training in a timely manner.
15. Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements.
16. Participate as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
17. Follow BDIS Environmental, Health and Safety (EH&S) policies and procedures.
18. 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
• Experience in data entry – BMRAM (Blue Mountain Regulatory Asset Management, SAP, etc.
• 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
• 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.