Senior Quality Engineer - Medical Device Validation & Transfer

Texchem Corporation Sdn Bhd; Bayan Lepas; On-site; MYR 67,000 - 100,000; Full time

Job summary

Texchem Corporation Sdn Bhd in Penang seeks a Quality/Validation engineer for managing validation activities in medical device context, focusing on product transfer and design control. You will contribute to risk evaluation and validation strategy.

You will mentor team, plan documentation, review designs and records, support audits, and drive continuous improvement of the quality management system.

This 6-month contract offers exposure to cross-functional teams across the Texchem group.

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing, Engineering, or Science.
• Minimum 5 years’ experience in validation with quality/process engineering for medical devices.
• Proficient in MS Office and data analysis with statistical tools.
• Basic knowledge of ISO 13485:2016, ISO14971; injection moulding knowledge is a plus.
• This is a 6-month contract position.

Responsibilities

• Participate and support in product development/ product transfer projects to meet quality requirements.
• Establish validation strategy and maintain validated state of equipment and processes via change control.
• Mentor validation/qualification activities to ensure effective process validation.
• Plan documentation and evaluation in project plans (Gantt charts).
• Review quality and product design documents to align with customer requirements.
• Ensure records and reports are identifiable and retrievable.
• Investigate, monitor, and report on customer feedback, claims, and complaints; close per timeline.
• Review validation events/discrepancies and verify CAPA implementation.
• Identify training needs and organize training to improve quality understanding.
• Initiate Statistical Process Control in QC and conduct data analysis.
• Provide assistance during audits; ensure QMS is implemented and maintained.
• Other duties as assigned by supervisor.

Skills

MS Office

Statistical analysis

Education

Bachelor's degree in Mechanical Engineering/ Manufacturing/ Engineering/ Science

Job description

Texchem Corporation Sdn Bhd in Penang seeks a Quality/Validation engineer for managing validation activities in medical device context, focusing on product transfer and design control. You will contribute to risk evaluation and validation strategy.

You will mentor team, plan documentation, review designs and records, support audits, and drive continuous improvement of the quality management system.

This 6-month contract offers exposure to cross-functional teams across the Texchem group.