Full Time Senior Customer Quality Engineer - Medical Device Manufacturing Jobs, in Mason & Co Johor - Maukerja

Objectives

• Establish and maintain quality controls to detect and contain nonconformance before customer shipment.
• Handle customer SCAR, returns and escalations through root cause investigation and permanent corrective action closure.

Principal Duties

• Act as the main quality contact for assigned customer accounts.
• Establish inspection plans and control plans based on customer requirements.
• Respond to customer SCAR and RTV, including containment, root cause analysis, CAPA and effectiveness verification.
• Lead root cause investigations using 8D methodology.
• Provide timely feedback to front-end processes based on customer and internal defects.
• Work with relevant departments on root cause analysis and continuous improvement.
• Maintain quality documentation, including PMP, PFMEA and Work Instructions.
• Own customer change notifications and review process, material, tooling and supplier changes against customer requirements.
• Ensure Quality Agreement requirements are understood, implemented and documented at plant level.
• Review lot records / DHR and release products with Certificate of Conformance.
• Support customer, certification body and internal audits.

Secondary Duties

• Lead and monitor IQ/OQ/PQ process validation.
• Prepare customer scorecards, PPM and Cost of Poor Quality reports for management review.
• Participate in Material Review Board activities, including nonconforming material disposition and customer deviation/concession requests.
• Identify opportunities to improve inspection cycle time and reduce manpower without compromising quality.
• Perform other ad-hoc duties as assigned.

Requirements

• Must have experience in medical device manufacturing.
• Experience in Quality Engineering, Customer Quality or Supplier Quality within a manufacturing environment.
• Good knowledge of quality tools such as 8D, RCA, CAPA, PFMEA and Control Plan.
• Experience handling customer SCAR, complaints, returns and quality escalations.
• Experience with quality documentation, audits and process validation.
• Familiarity with medical device quality systems and regulatory requirements.