Quality Engineer 1

Teleflex; Kampung Jentz Settlement; On-site; MYR 50,000 - 60,000; Full time

Job summary

A global medical technology provider in Malaysia is looking for a Validation Engineer to support quality assurance activities related to product validation and regulatory compliance. The role involves reviewing validation documents, coordinating with suppliers, and ensuring compliance with ISO-13485 standards. Candidates should hold a relevant degree and have 2-3 years of experience in engineering, with strong skills in technical writing and communication. The position offers an opportunity to work in a dynamic environment focused on improving healthcare solutions.

Qualifications

• 2-3 years of experience in a related field is required.
• Must have an engineering background, preferably in Medical Technology or Packaging.
• Must be self-motivated with excellent interpersonal skills.

Responsibilities

• Review and approve validation documents to ensure quality.
• Coordinate validation activities for the Kamunting site.
• Train suppliers on validation requirements and documentation.

Skills

Technical writing

Communication skills

Statistical process control

Documentation practice

Interpersonal skills

Education

Degree or Diploma in Engineering, Science or Math

Degree in Chemistry, Polymer Science, or Statistics

Certificate in Quality Engineering

Tools

Word

Excel

PowerPoint

QC tools

Job description

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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

• Review, coordinate and approve validation and verification document of proposed materials, packaging or finished products to ensure their quality and functionality.
• Support in coordinating process, equipment, spreadsheet, software, and test method validation activities for Teleflex Kamunting site.
• Review process, equipment, test method, spreadsheet and software validation protocol and final report.
• Support supplier and change management programs.
• Assist in Statistical process control and process capability assessment in the validation program.
• 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.
• Liaise and coordinate with suppliers, R&D, Global Packaging and QA/RA on regulatory requirements.
• 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)
• Support suppliers for documentation improvement if needed
• Responsible for ensuring supporting documents from supplier is sufficient for validation or verification activities and comply with Teleflex requirements.
• Responsible to communicate and update the validation or verification status to respective personnel and value stream members for mutual understanding.
• Ensure supplier’s qualification comply to ISO-13485 requirement.
• Responsible for data verification in validation and ensure robustness

Education / Experience Requirements

Qualification:
Degree or Diploma in Engineering, Science or Math, Degree in Chemistry, Polymer Science, Statistics and Certificate in Quality Engineering.

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