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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.
Assess the dimensional accuracy of machined parts using the appropriate inspection methodology & 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)
Ensures timely completion of daily work assignments
Support and contribute to the attainment of the department/business goals
Interact effectively with peers
Adhere to Client San Jose's Quality System requirements & client Values
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
Requirements:
1-2 years’ experience working as Quality Assurance Inspector in a GMP, FDA or ISO 9000 environment
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