Packaging Engineer

Straits Orthopaedics (Mfg) Sdn Bhd; Batu Kawan; On-site; MYR 60,000 - 90,000; Full time

Job summary

Straits Orthopaedics (Mfg) Sdn Bhd, located in Batu Kawan, Malaysia, seeks a candidate to lead and participate in process validation, lab analysis, and documentation for new products. The role requires experience in medical device manufacturing, ISO13485, and risk management practices.

Candidate should have a biology/chemistry background and be able to work at Teluk Kumbar and Batu Kawan by Q4 2025. The company exports to major markets and holds ISO and FDA registrations.

Qualifications

• Degree in biology, microbiology, chemistry, or chemical engineering.
• 3 years related experience in medical device/pharmaceutical manufacturing and related areas.
• Trained on ISO13485, ISO9001 and medical device regulatory requirements and risk management.
• Manufacturing process validation, microbial contamination sampling, root cause analysis and problem solving, risk assessment.
• Willingness to work in Teluk Kumbar and Batu Kawan by Q4 2025.

Responsibilities

• Lead, execute and participate in process, equipment and software validation activities.
• Study and analyze lab test results or reports.
• Create or design documentation for new product processes.
• Carry out process capability studies for equipment and processes.
• Establish and maintain pFMEA and work instructions.

Skills

Process validation

Root cause analysis

Problem solving

Documentation

Quality systems

Education

Degree in biology, microbiology, chemistry, or chemical engineering

Tools

ISO 13485

ISO 9001

FDA 21 CFR Part 820

Job description

• 1. Lead, execute and participate process, equipment and software validation activities from time to time.
• 2. To study and analyze lab test results or reports.
• 3. Create or design necessary documentation or process for new product
• 4. Carry out process capability studies for equipment and process if necessary.
• 5. Establish, update and maintain pFMEA.
• 6. Establish work instruction and other required process documents.
• 7. Monitor and ensure processes are adhere to requirements.
• 8. Work with project team for new project.
• 9. Liase with various functions group in order to ensure completion of tasks or project on time.
• 10. To attend conference calls for relevant project.
• 11. To lead or participate in problem solving meeting regarding relevant process.
• 12. Troubleshoot for process abnormalities or out of specifications.
• 13.To comply with Straits procedures, ISO 13485, ISO11607, FDA Regulations and relevant standard and utilize associate document and WI to assure the job is done accordingly.
• 14. To assist superior on other tasks

Job requirements

Degree in biology, microbiology, chemistry, or chemical engineering.

Preferably 3 years related experience in the medical device or pharmaceutical product manufacturing, product cleaning and packaging, cleanroom operation and environment maintenance and/or manufacturing process validation.

Preferably trained on ISO13485, ISO9001, medical device related regulatory requirements and risk management.

Preferably attained the skill of manufacturing process validation, microbial contamination sampling, systematic root cause analysis and problem solving, and risk assessment.

Able to work at Teluk Kumbar and Batu Kawan by Q4 2025.

Straits Orthopaedics (Mfg) Sdn Bhd ("Straits") is a situated at Batu Kawan. Straits is a medical devices manufacturer and our principal business is the production, cleaning and packaging of orthopaedics devices and accessories (trauma and reconstructive ) and wound care products. Mainly, all our product are exported to our customers in the United States of America, China, Japan, Europe etc. Straits is a company certified with ISO 13485 and ISO 9001. Our company is registered with US FDA and is required to comply with 21 CFR Part 820. Currently, we have approximately 1200 employees and due to our expansion, we are looking for qualified candidate to join our team as :