Medical Device Quality Engineer – CAPA & Compliance

Pentamaster Corporation Berhad; Penang; Presencial; MYR 72.000 - 144.000; Jornada completa

Descripción de la vacante

Pentamaster Corporation Berhad in Penang is seeking a Quality Engineering Engineer (Medical Device) to join our Healthcare & Medical division on a full-time basis. You will ensure medical device products meet quality, safety and regulatory standards, collaborating across design, manufacturing and regulatory affairs.

You will develop and maintain QA protocols, perform audits, CAPA, risk assessments (FMEA), and support FDA, CE marking and GMP compliance.

Formación

• Bachelor's degree in Engineering or equivalent qualification.
• 3–5 years in quality engineering/QA, preferably in medical devices or pharma.
• Strong knowledge of ISO 13485, FDA, GMP and CE marking.
• Experience with SPC, DOE and CAPA methodologies.
• Experience with quality management software and ERP systems is advantageous.
• ASQ CQE or Six Sigma certification is desirable.

Responsabilidades

• Develop, implement and maintain QA protocols for medical device manufacturing.
• Conduct audits, inspections and testing across production stages.
• Identify deviations and implement CAPA actions.
• Collaborate with design, manufacturing and regulatory teams.
• Prepare and maintain SOPs, work instructions and quality records.
• Support FDA, CE and other regulatory activities.
• Perform FMEA risk assessments to mitigate quality risks.
• Provide training on quality standards to staff.
• Maintain calibration and validation records for equipment.
• Drive continuous improvement in product quality and efficiency.

Conocimientos

Quality engineering

CAPA

SPC

DOE

Root cause analysis

Educación

Bachelor's degree in Engineering

Herramientas

ERP

Document management systems

Descripción del empleo

Pentamaster Corporation Berhad in Penang is seeking a Quality Engineering Engineer (Medical Device) to join our Healthcare & Medical division on a full-time basis. You will ensure medical device products meet quality, safety and regulatory standards, collaborating across design, manufacturing and regulatory affairs.

You will develop and maintain QA protocols, perform audits, CAPA, risk assessments (FMEA), and support FDA, CE marking and GMP compliance.