QA Engineer: Injection Molding Quality Leader

Sunningdale Tech Penang Sdn Bhd

Batu Kawan

On-site

MYR 60,000 - 100,000

Full time

5 days ago
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Job summary

Sunningdale Tech Penang Sdn Bhd is seeking a Quality Assurance Engineer to oversee the implementation and maintenance of the QMS across plastic injection molding and related processes. You will lead IPQC activities, drive continuous quality improvements, and coordinate with Process Engineers and CQEs to resolve quality issues.

The ideal candidate has 5+ years in QA within plastics or medical device manufacturing, and a strong knowledge of ISO 13485 and ISO 9001.

Qualifications

  • Degree in Engineering, Quality Management, Manufacturing, or related field.
  • 5 years plus experience in Quality Assurance within plastic injection molding or medical device manufacturing.

Responsibilities

  • Ensure quality system requirements are implemented, reviewed, and maintained per customer and regulatory standards.
  • Maintain effective QA systems to ensure products meet customer specifications.
  • Lead QA activities for plastic injection molding, lacquering, printing, laser etching, and sub-assembly processes.
  • Guide IPQC team to perform daily inspection activities per procedures.
  • Monitor SPC implementation to ensure process control and product quality.
  • Develop ECOs, PIPs, PMPs, and WIs for related processes.
  • Review QA reports, inspection records, and documentation.
  • Participate in customer complaint investigations and root cause analysis for corrective actions.
  • Support quality issue investigations with Process Engineers and CQEs.

Skills

Quality Assurance
Statistical Process Control (SPC)
Root Cause Analysis
FMEA
CAPA
ISO 13485
ISO 9001

Education

Engineering / Quality Management degree

Tools

MSA
8D Problem Solving
CAPA system

Job description

Sunningdale Tech Penang Sdn Bhd is seeking a Quality Assurance Engineer to oversee the implementation and maintenance of the QMS across plastic injection molding and related processes. You will lead IPQC activities, drive continuous quality improvements, and coordinate with Process Engineers and CQEs to resolve quality issues.

The ideal candidate has 5+ years in QA within plastics or medical device manufacturing, and a strong knowledge of ISO 13485 and ISO 9001.

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