Quality Assurance Inspector

Position Quality Assurance Inspector Location San Jose, CA Duration 3 Months Hours per Week 40.00 Shift 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) Responsibilities Perform documentation verification, visual and 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 dimensional accuracy of machined parts using the appropriate inspection methodology and measuring tools. Conduct a thorough documentation review ensuring that all recorded information is complete and meets the requirements 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 quality records are complete when saving or uploading to SAP. Follow standard operating procedures (SOP). Ensure timely completion of daily work assignments. Support and contribute to the attainment of the department and business goals. Interact effectively with peers. Adhere to BDB San Jose's Quality System requirements and client values. Participate and contribute to continuous improvement activities. Monitor changes to applicable procedures and complete training in a timely manner. Keep abreast of the basic requirements for compliance in one's area of work and comply with those requirements. Participate in training on regulatory issues affecting one's area of work and bring regulatory compliance questions or issues to the attention of management. Follow BDIS Environmental, Health and Safety (EH&S) policies and procedures. Take responsibility for safety in the immediate work area and participate in EH&S programs, notifying supervisors of all observed hazardous conditions or unsafe work practices and, where appropriate, providing recommendations on maintaining a safe work environment. Qualifications Experience performing the duties and responsibilities described above. Experience with first article inspection. Experience in data entry using BMRAM (Blue Mountain Regulatory Asset Management), SAP, etc. Highly detail oriented. Ability to read and interpret engineering drawings. Very good understanding of Good Documentation Practices. Good organizational and prioritization skills. Ability to multitask. Strong problem‑solving skills. Computer literate with basic knowledge of Microsoft Windows, Office, SAP, Minitab, etc. Adaptive, collaborative, agile. Proficient verbal and written communication skills. Team‑oriented with a commitment to the success of the team and organizational goals to track and complete assignments. Experience working under GMP, ISO 9000, or FDA environment. Education and Experience High School Diploma or equivalent. 1–2 years of experience as a Quality Assurance Inspector in a GMP, FDA, or ISO 9000 environment. #J-18808-Ljbffr