Senior Engineer - Quality (Contract)

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

To implement, maintain and continually improve the effectiveness of the company’s Quality Management System, especially on product transfer and design control.

To evaluate the process risk and to lead process validation activities.

Assist site Quality team by providing guidance and training on product transfer and design control activities.

Responsibilities

Participate and support in products development/ product transfer project and to ensure the quality requirements including customer requirements are addressed, established and documented.

Establish validation strategy and approach to ensure cost effective validation process being developed through risk management, and maintain the validated state of the equipment, system and process through change control and validation.

Mentoring validation/ qualification exercise to ensure process validation are carried out effectively and successfully.

During project planning on new product transfer or new product development, ensure all the required documentation and evaluation are planned and included in the Gant Chart.

Review all the quality and product design documents, ensure the activities are sufficiently and correctly documented, and align with customer requirements.

Ensure all records and reports maintained with identification, traceability and retrievability at individual sites.

Perform investigation, monitoring, reporting on customer feedback, claims (CA/PA), customer complaints and follow-up on the report closure according to committed timeline. Analyze the corrective and preventive action to further identify the areas for continues improvement in the quality system.

Review validation event/ discrepancies and ensure the countermeasure and Corrective Action/ Preventive Action (CA/PA) are verified on its implementation and monitored for its effectiveness before closure.

Identify training needs and organize training to improve the understanding of the team to meet quality standards.

Initiate products Statistical Process Control in the QC team and conduct data analysis.

Provide assistance to site quality team during audits.

Ensure that the Quality Management System requirement is implemented and maintained according to procedures.

Other assignments as instructed by superior or other person appointed by the company from time to time.

Requirements

Degree in Mechanical Engineering/ Manufacturing / Engineering / Science or equivalent.

Minimum 5 years’ experience in validation with quality / process engineering for medical device industry.

Required skill (s): MS Office and perform data analysis with statistical tools.

Basic knowledge in ISO 13485:2016, ISO14971 and injection moulding process would be an added advantage.

*This is a 6-months Contract position.*

Texchem Group, headquartered in Penang, Malaysia, has evolved from a textile chemical trader in 1973 into a Malaysian multinational conglomerate with diverse business interests. Over five decades, we have grown through innovation, diversification, and continuous improvement, establishing operations across ASEAN and Japan.

Today, Texchem comprises five core business divisions: Industrial, Restaurant, Polymer Engineering, Food, and Venture Business. Guided by our vision to be the First Choice of People, we are committed to creating exceptional experiences for our people while delivering innovative solutions and sustainable growth for our stakeholders.

Texchem Group, headquartered in Penang, Malaysia, has evolved from a textile chemical trader in 1973 into a Malaysian multinational conglomerate with diverse business interests. Over five decades, we have grown through innovation, diversification, and continuous improvement, establishing operations across ASEAN and Japan.

Today, Texchem comprises five core business divisions: Industrial, Restaurant, Polymer Engineering, Food, and Venture Business. Guided by our vision to be the First Choice of People, we are committed to creating exceptional experiences for our people while delivering innovative solutions and sustainable growth for our stakeholders.