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Sterilization Engineer
Sterilization EngineerTeleflex • Kamunting, Perak, Malaysia
Sterilization Engineer

Sterilization Engineer

Teleflex • Kamunting, Perak, Malaysia
5 days ago
Job description

Expected Travel

Up to 25%

About Teleflex Incorporated

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

Provide support for sterilization and microbiological methods and processes related to products designed and manufactured by Teleflex. Evaluate new products and changes to product, including custom and made‑to‑order kits, for impact of sterilization. Responsible for the environmental control in Teleflex facilities. Lead and evaluate the microbiological tests performed to the product and the manufacturing areas.

Principal Responsibilities

  • Provide support to maintain sterilization programs / policies for Teleflex Medical to endure all products and processes comply with the regulatory standards.
  • Ensure company documentation related to sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
  • Provide support to evaluate the impact / efficacy of existing sterilization methods on new products or new product / packaging designs.
  • Provide support to evaluate and document the impact of new or modified manufacturing processes or environmental related changes on existing sterilization methods.
  • Provide support to evaluate the effectiveness of existing sterilization methods on custom or made‑to‑order kits.
  • Provide site support to ensure company-wide, consistent and compliant methods are followed for : EO Residuals, bioburden monitoring, environmental monitoring, clean‑room practices, and bacterial endotoxin testing.
  • Develop procedures related to environmental control.
  • Establish limits for the bioburden, environmental monitoring of water and product.
  • Develop the protocols of microbiological qualification of new or modified manufacturing areas.
  • Coordinate routine sample collection for the product testing to ensure product / process controls are maintained in compliance with existing standards and procedures.
  • Perform miscellaneous projects and duties as directed by the immediate manager.
  • Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

  • B.S. or B.A. Degree in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background is preferred. Other B.S. or B.A. degrees will be considered.
  • Minimum of 1 - 3 years of experience in medical device industry (preferably).
  • Specialized Skills / Other Requirements

  • Knowledge / experience in EO and gamma radiation sterilization
  • Strong technical writing ability preferred
  • Statistical knowledge (DOE, SPC, Sample comparison, etc.) preferred
  • Strong communication skills (written and verbal)
  • Regulatory, cGMP, QSR knowledge base is preferred but not required
  • Computer literate (MiniTab, Word, Excel, etc.)
  • Negotiation and strong problem solving skills
  • Ability to communicate and operate effectively with multiple teams
  • Adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts, reasoning ability
  • 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.

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    Engineer • Kamunting, Perak, Malaysia

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