Kerja Sepenuh Masa, Quality Assurance Engineer di Trajan Scientific And Medical Pulau Pinang - Maukerja

Quality Engineer

Trajan Scientific & Medical Malaysia Sdn Bhd | Penang, Malaysia

About the Role

We are looking for a Quality Engineer to join our team in Penang and play a key role in ensuring the quality, compliance and reliability of our syringe manufacturing operations.

This role will be responsible for investigating customer quality issues, supporting quality control and inspection activities, maintaining calibration and quality records, and driving effective corrective and preventive actions. You will work closely with Production, Operations, Engineering, Quality and other stakeholders to identify issues, implement solutions and continuously improve our processes.

The role also provides an opportunity to work with both internal and external stakeholders, supporting customer complaint investigations, audits and the continuous improvement of Trajan's Quality Management System (QMS).

Key Responsibilities

Customer Quality & Investigations

• Manage and close Customer Quality Complaints / OQRs in a timely and effective manner in accordance with QMS requirements.
• Lead investigations into reported customer issues, ensuring appropriate quality tools and root-cause analysis techniques are applied.
• Develop and implement effective corrective and preventive actions to prevent recurrence.
• Manage products placed on QHOLD, including communication, investigation, containment and resolution.
• Maintain accurate and complete records of customer quality issues in the Pronto CRM system.
• Prepare investigation reports and communicate findings and resolutions clearly to internal and external stakeholders.

Quality Control & Manufacturing Support

• Provide quality oversight of syringe manufacturing processes to ensure compliance with approved procedures, work instructions and QMS requirements.
• Conduct and support in-process and final inspections, line clearance and quality verification activities.
• Support Incoming Quality Assurance (IQA) activities when required.
• Perform QC measurements including component tolerance checks, gauge verification and investigation of assembly-related quality issues.
• Conduct regular production line walks to proactively identify quality risks, deviations and opportunities for improvement.
• Escalate quality issues promptly to Quality Management and Operations to ensure effective containment and resolution.
• Support Out Box Inspection (OBI) activities when required.

Calibration & Quality Systems

• Support the management and maintenance of the calibration gauge programme, including calibration records and traceability.
• Ensure measuring equipment and gauges are appropriately controlled and maintained.
• Maintain accurate quality records and ensure data integrity and traceability within relevant quality systems.
• Operate and maintain Pronto Inventory Quality Transactions for the Malaysia QA site.

QMS, Audits & Continuous Improvement

• Work closely with the Senior Quality Engineer to maintain a consistent and standardised approach to the Trajan global QMS.
• Support internal and customer audits, including preparation, execution and follow-up actions.
• Support investigation and closure of quality-related findings and corrective actions.
• Conduct QMS toolbox talks and quality meetings with Production and Operations teams on topics such as measurement techniques, manufacturing processes and calibration requirements.
• Provide quality support across business functions on product quality, process compliance and continuous improvement initiatives.
• Support the TMS team in achieving efficient and effective business processes and overall quality objectives.

What We’re Looking For

• Bachelor's Degree in Engineering, Quality, Manufacturing, Science or a related discipline.
• Experience in a Quality Engineering / Quality Assurance / Manufacturing environment, preferably within medical device, pharmaceutical, electronics or other regulated manufacturing industries.
• Knowledge of Quality Management Systems, root-cause analysis, CAPA and quality investigation methodologies.
• Experience with inspection, measurement and calibration processes.
• Strong analytical and problem-solving skills with the ability to investigate issues and identify practical solutions.
• Good understanding of manufacturing processes and quality control principles.
• Strong communication skills, with the ability to work effectively with Production, Engineering, Quality, Operations and external customers.
• Good documentation and report-writing skills.
• Ability to manage multiple quality issues and drive assigned cases through to closure.
• Proactive, detail-oriented and comfortable working in a manufacturing environment.
• Experience with ISO 13485 and/or medical device regulatory requirements will be an advantage.
• Familiarity with Pronto CRM/ERP or similar quality management systems will be an advantage.

Why Join Trajan?

At Trajan, you will have the opportunity to work in a global scientific and medical technology organisation where quality, innovation and continuous improvement are central to what we do.

You will work alongside a collaborative team and contribute directly to the quality and reliability of products used in scientific and healthcare applications.

Location: Nibong Tebal, Penang, Malaysia

Employment Type: Full-time

Apply Now

If you are a quality professional who enjoys investigating problems, improving processes and working with cross-functional teams to deliver high-quality products, we would like to hear from you.

• Join Trajan Malaysia and be part of a team committed to quality, innovation and continuous improvement.

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