The Quality Engineer is responsible for: • Non-conforming products process management. • Process improvements, TCA coordinator & follow-up, reports. • Analyzing trends and supporting the improvement of the production quality. • Activities related to Operations stabilization and improvements. • Supplier Change Request (SCR) process management. • CSA/UL compliance including audits, updating of CSA/UL critical components list, interaction with UL/CSA representatives. • Reviewing and introducing new and revised processes in Operations. • Calibration and preventive maintenance (PM) related activities. • Support change control processes from QA perspective Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: • Non-conforming products process management o Manages Non-conformance methodology: Facilitate weekly meetings (PET) NC follow up and reports NC Product disposition Conduct and support NC investigations (internal and supplier nonconformances) NC approval o Supporting production team in analyzing and reporting quality events o Performing analysis of nonconforming products and presenting data in DRB. Leads HTC calibration and maintenance process for equipment in development and operations areas incl.
tool for periodic calibration/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 o Continuously improves manufacturing processes o Coordinates with the Production team to measure and improve Manufacturing processes • Operations QA improvements, TCA coordinator follow-up, data analysis, new/revised processes implementation such as e DHR, ETQ, e CMMS Rollout, QC activities o Supports continuous improvement of manufacturing processes and Reduction of non-quality costs o Supports new and revised processes in Operations o Process/Station Audits, when required o Perform TCA coordinator activities & follow-up o Working on entering or revising new processes in Operations such as e DHR, ETQ, e CMMS o Improve Production Team skills with c GMP, GDP o Ensures Product Quality compliance through QC and Final Release: o Performs QC activities.
For J&J employees only: Final System Release. • Ensure CSA/UL compliance o CSA/UL audit compliance o CSA/UL CAPA performance o Collaboration with CSA/UL partners • Supplier Change Request (SCR) process management • Support and facilitate SCR process: Facilitate weekly meetings SCR follow up and promotion • Support change control processes from QA perspective o Support activities related to testers development /update through production o Review and approve MCOs/DMRs o Support in house/supplier validation activities and conduct PV assessments for process change • General o Communicate business related issues and opportunities to next management level o Follow all Company guidelines related to Environment, Health & Safety practices o Ensure personal and Company compliance with Company policies and applicable laws o Perform other duties assigned as needed Education or Training: Practical Engineer / BSc in Engineering / BA degree or Quality Assurance, CQE is an advantage. Experience: Previous experience in QA field in medical system or medical device company is an advantage. Required Knowledge • Auditing, Project management, Operations processes • High level English: Speaking, Reading, and writing Required Skills or Abilities • Good communication skills, both verbal and written in English • Good interpersonal relations • Team player • Reliable and accurate Certifications or Licenses • Preferred CQE, Internal auditor