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Process Validation Engineer
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