Senior Quality Engineer

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