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Process Validation Engineer

  • Full Time, onsite
  • Agensi Pekerjaan Career Channel Sdn Bhd
  • Shah Alam, Malaysia
RM 4,000 - RM 5,500 / month

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  • Perform process validation and capability.
  • Perform software validation and ensure QMS compliance.
  • Drive quality/manufacturing projects and initiatives utilizing DMAIC and/or Lean methodologies, APQP, and/or SPC to achieve and sustain improvements.
  • Perform MSAs.
  • Support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technologies.
  • Champion activities including containment, root cause analysis, corrective actions, and follow-up/verifications concerning customer complaints, ensuring complaints are closed within the target time frame.
  • Lead/facilitate or participate in risk analysis using FMEA, Fault Tree, or other suitable methods for existing and/or future processes and products.
  • Lead/facilitate or participate in root cause analysis for internal and external nonconformities using 5-why’s, fishbone, or other suitable methods, and challenge corrective actions through verification of effectiveness.
  • Lead/facilitate or participate in continuous improvement projects using Lean, DMAIC, Kaizen methodologies.
  • Physically walk processes, with/without team, to gain consensus for key areas for improvement.
  • Develop and administer training to personnel on quality functions, methodologies, and quality issues as required.
  • Create documentation, reports, presentations, and records consistent with internal and external requirements, complying with ISO, safety, environmental, and/or regulatory agencies.

Job Requirements:

Education:

  • Bachelor's degree in Industrial Engineering, Chemistry, or Material Science. Additional certifications in ASQ, SPC, Lean, or Six Sigma are a plus.

Experience:

  • 1-2 years in a Quality Assurance role. Experience with ISO 9001:2015, GMP, and automotive/medical products is a plus.

Job Types: Full-time, Permanent

Pay: RM4,000.00 - RM5,500.00 per month

Benefits:

  • Health insurance

Schedule:

  • Monday to Friday

Work Location: In person