Medical Device Process Engineer: Qualification & Improvement

SteriPack Asia Sdn Bhd (Trading as Ensera); Teluk Gong; On-site; MYR 50,000 - 73,000; Full time

Job summary

SteriPack Asia Sdn Bhd (Trading as Ensera) is seeking a Process Engineer to lead qualification activities for production equipment and tooling, and drive process improvements in the Medical Device/Pharmaceutical sector.

You will collaborate with NPI and coordinate with vendors, with a degree in mechanical/manufacturing engineering or science, 2+ years of relevant experience, ISO 13485 and GMP knowledge, and proficiency in English and Bahasa Malaysia.

Qualifications

• Degree in engineering (mechanical/manufacturing) or science.
• Minimum 2 years of relevant experience in manufacturing or medical industry.
• Knowledge of ISO 13485 and GMP is advantageous.
• Ability to lead and work with minimum supervision.
• Good written and spoken English and Bahasa Malaysia.
• Proficient with MS Office.

Responsibilities

• Manage qualification activities related to process equipment, jig, fixture and tooling used by Production.
• Lead process improvement activities for Production processes.
• Review and update routing and product structure for Production processes.
• Analyze downtime and propose improvement plans for process equipment.
• Coordinate with vendors for on-site work and equipment arrangements.
• Collaborate with NPI on process development and qualification of new equipment.
• Investigate non-conformances and lead related activities in Production.
• Lead troubleshooting and testing on process equipment as needed.
• Maintain documents/records in line with QMS requirements and prepare for audits.

Skills

Leadership

Teamwork

Analytical thinking

English proficiency

Bahasa Malaysia

Education

Engineering degree (mechanical or manufacturing) or Science

Tools

Microsoft Office

Job description

SteriPack Asia Sdn Bhd (Trading as Ensera) is seeking a Process Engineer to lead qualification activities for production equipment and tooling, and drive process improvements in the Medical Device/Pharmaceutical sector.

You will collaborate with NPI and coordinate with vendors, with a degree in mechanical/manufacturing engineering or science, 2+ years of relevant experience, ISO 13485 and GMP knowledge, and proficiency in English and Bahasa Malaysia.