SENIOR QUALITY ENGINEER

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 eDHR, ETQ, eCMMS 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 eDHR, ETQ, eCMMS o Improve Production Team skills with cGMP, 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 Qualifications 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