SECTION 1: JOB SUMMARY* The Production QC Specialist is responsible for QC activities in production related to goods to be shipped, verifying production lines quality standards compliance, supplier’s guidance with BWIIL needs and requirements such as Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), calibration support, and quality requirements (visual inspection support). SECTION 2: DUTIES & RESPONSIBILITIES* In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: 61 Quality Control o Documentation and visual inspection of QC reviews for finished goods, RMA, Kits and spare parts at HTC production or supplier sites 61 Production and RMA Lines compliance with quality standards as ISO13485 o Verifying that production and RMA lines are working per defined procedure by periodically line patrol, reporting of findings and follow-up o Supports continuous improvement of manufacturing processes and Reduction of non-quality costs o Supports new and revised processes in Operations and Supplier sites 61 Suppliers guidance with BWIL requirement for Good Manufacturing Practices o Guides BWIIL suppliers regarding GMP, GDP and visual inspection. 61 Calibration and maintenance o Manages Calibration and maintenance plans and activities. o Executes Calibration follow-up and reporting - Organize, approve, and file calibration reports o Update calibration tools data o Handling calibration tools QA inventory & storage area o Initiates and follows up on Corrective actions following NC analysis 61 processesNon-conforming management support o Participates in the weekly meetings (PET) o Conduct and support NC investigations (internal and supplier nonconformances) o Supporting production team in analyzing and reporting quality events
General o Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. o For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed
Qualifications/任职要求:
SECTION 3: EXPERIENCE AND EDUCATION* Education/Training: High school diploma or more. Experience: At least 2 years of experience in Quality Control/Management SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* Required Knowledge 61 Good communication skills, both verbal and written, in English and Hebrew Required Skills or Abilities 61 Technical skills 61 Team player 61 Trustworthy, will responsibly carry out tasks 61 Reliable and accurate 61 Good sense of urgency 61 Understanding of BOMs, drawings, specifications, and electrical schemes (an advantage)