Quality Assurance

Roles & Responsibilities

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 Client San Jose's Quality System requirements & client 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.

Experience Required

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

Skills & Certifications

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

Eligibilities & qualifications

EDUCATION

High School Diploma or equivalent