Packaging Engineer 2

Teleflex; Kampung Jentz Settlement; On-site; MYR 50,000 - 70,000; Full time

Job summary

A global medical technology company in Kampung Jentz Settlement, Malaysia is seeking a Validation Coordinator to oversee validation and verification of materials, ensuring compliance with ISO standards. Ideal candidates will have a degree in Engineering or Science and a background in Medical Technology. Responsibilities include collaborating with suppliers, conducting tests, and supporting documentation improvement efforts. Join a dynamic team dedicated to enhancing healthcare solutions.

Qualifications

• Two to three years’ experience in a related field.
• Engineering background in Medical Technology, Packaging or Chemical Engineering.
• Up to date knowledge on validation requirements, ISO standards and medical device requirements.

Responsibilities

• Conduct and coordinate validation and verification of materials and products.
• Undertake margin expansion and cost reduction initiatives.
• Liaise with suppliers and QA/RA on regulatory requirements.

Skills

Technical writing

Communication

Interpersonal skills

Validation knowledge

ISO standards compliance

Education

Degree in Engineering, Science or Math

Degree in Manufacturing, Polymer Science or equivalent

Tools

Word

Excel

PowerPoint

QC tools

Job description

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

• 1. Conduct and coordinate validation and verification of proposed materials, packaging or finished products to ensure their quality and functionality.
• 2. Plan and execute validation/verification testing as per procedures.
• 3. Undertake margin expansion, PPV and CIP’s opportunities for site and corporate where necessary in the are of material or packaging substitutions initiatives and cost reduction where applicable.
• 4. Responsible for writing protocols and reports related to sustaining, compliance and packaging validation or verification projects.
• 5. Liaise and coordinate with supplier, Global Packaging and QA/RA on regulatory requirements.
• 6. Consult with vendor or suppliers in identifying new materials / packaging.
• 7. Conduct test to evaluate the performance of the new materials or packaging changes as per standard requirements.
• 8. Conduct briefing and / or training on validation requirements for suppliers to ensure suppliers meet expectations on validation for documentation purposes such as traceability and good documentation practice. (GDP)
• 9. Interact with production, suppliers, and internal support department to ensure new qualified parts are ready for production use.
• 10. Support suppliers for documentation improvement if needed
• 11. Responsible for ensuring supporting documents from supplier is sufficient for validation or verification activities and comply with Teleflex requirements.
• 12. Responsible to communicate and update the validation or verification status to respective personnel and value stream members for mutual understanding.
• 13. Ensure supplier’s qualification comply to ISO-13485 requirement.
• 14. Responsible for data verification in validation and ensure robustness.

Education / Experience Requirements

Qualification : Degree in Engineering, Science or Math, Degree in Manufacturing, PolymerScience, or equivalent

Experience :

• 1. Two to three years’ experience in related field
• 2. Must have Engineering background in Medical Technology, Packaging, plastic or chemical engineering.
• 3. Must possess good technical writing ability including proficiency in Word,Excel, PowerPoint and QC tools
• 4. Should have up to date knowledge on the validation requirements, ISO standards, procedures and good knowledge in medical device requirements
• 5. Excellent written and verbal communication skills
• 6. Self-motivated and drive for excellent with good interpersonal skills for working across multifunctional teams
• 7. Ability to articulate issues related to validation and manage multiplepriorities with least supervision

Specialized Skills / Other Requirements

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

Teleflex is an equal opportunities employer.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.