SENIOR QA ENGINEER (PROCESS VALIDATION)

Overview

The employee is responsible to qualify and validate all manufacturing processes (including test method, new machine installation and new production introduction) and implement process control based on PFMEA. He / She shall apply QC / QA tools to determine process CTQ and controls to ensure products and processes comply with relevant specifications. The employee is responsible for continuously improving processes and achieving optimum product quality by using CAPA methodologies. He / She will work independently to determine appropriate actions to fulfill management objectives and support the investigation of non-conformances by developing CAPA and using quality tools such as root cause analysis, statistical sampling, capability studies, problem solving, or other statistical methods.

Job Functions include but are not limited to

• Perform process validation and capability.
• Perform software validation and ensure QMS compliance.
• Drive quality / manufacturing project initiatives utilizing DMAIC and / or Lean methodologies, APQP, and / or SPC to achieve and sustain improvements.
• Perform MSAs.
• Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process / technology.
• Champion activities including containment, root cause analysis, corrective actions, and follow-up / verifications concerning customer complaints, closing complaints inside the target time frame.
• Risk analysis - Lead / facilitate or participate on a team using FMEA, Fault Tree or other suitable methods for existing and / or future processes and products.
• Lead / facilitate or participate on a team focusing on root cause analysis for internal and external nonconformities using 5-Why’s, fishbone or suitable methods, and challenge corrective actions through verification of effectiveness.
• Lead / facilitate or participate on continuous improvement projects using Lean, DMAIC, Kaizen methodologies.
• Physically walk processes, with / without team, gaining consensus for key areas for improvement.
• Develop and administer training to personnel on the quality function, quality 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.
• Provide professional verbal and written communication to external and internal parties, complying with company policies.
• Champion any projects / tasks / duties defined by the Quality Head with metrics that track achievable goals.

Job Requirements

Education

Preferably with a science background with a degree in Industrial Engineering, Chemistry or Material Science. Additional professional certifications such as ASQ, SPC, Lean, Six Sigma are an added advantage.

Experience

2 - 4 years of work experience in Quality Assurance. Exposure to ISO 9001 : 2015 QMS, GMP, Automotive and Medical products working environment is an added advantage.

Skills

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