Sterilization Engineer (SPP-303)

Date: 03-Jun-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 3842

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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

Principal Responsibilities

1.    Sterility Assurance Quality system documentation shall meet the requirements of 21 CFR Part 820, ISO 13485, the European medical device directives, the Japanese Pharmaceutical Affairs Law, and other quality system regulations and standards as appropriate.
Complete Sterility Assurance transfer plans, sterilization and microbiology assessments, protocols and reports as per regulatory requirements.
2.    Liaise with transfer leaders to co-ordinate product samples and scheduling with test laboratories (internal and external). 
3.    Liaise with external laboratories, as applicable, to complete test method validations and testing.
4.    Support cleanroom installation and qualification activities including protocol and report reviews with the applicable manufacturing sites. 
5.    Liaise with the manufacturing sites to ensure the procedures for cleanroom testing, product testing and final release associated with product transfer are complete. 
6.    Ensure microbial test methods are validated with the applicable laboratories.
7.    Ensure proper communication and act as a liaison and partner with regulatory, quality, microbiology, sterilization, product development and sales & marketing personnel to ensure project success.
8.    Support in biocompatibility assessments, protocols and reports as per regulatory requirements
9.    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.   
10.    Represent Sterility Assurance at the Strategic Manufacturing Transfer leadership meetings.
11.    Perform other duties requested by management
12.    For gamma families, this includes but is not limited to reviewing the bio-burden levels and morphology, assessing for transfer to a new sterilization facility, determining whether a new dose substantiation is required; re-establishing the dose; dose mapping; density analysis; etc.
13.    For EO families, this includes but is not limited to, remaining in the existing cycle/location, potential for adoption into an existing cycle in an alternate sterilization site, relocation of the sterilization process in a newly created cycle with full validation required (biological indicator appropriateness versus natural product sterility, residual testing, sub-lethal cycles, fractional cycles, full cycles, etc.)
14.    To ensure the implementation and maintenance, within the department, of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
15.    Ensure Program conforms to the Quality System Regulation (QSR), CMDCAS, MDD 93/42/EEC, MDR, ISO 13485 and other relevant Standards. 
 

Education / Experience Requirements

Qualification    :    

•    Degree in Microbiology, Biology, Medical Technology or Other related field. 

Experience     :    

•    2-3 year’s experience in irradiation and ethylene oxide sterilization methods with knowledge of  steam and gas plasma sterilization methods desirable.
•    Knowledge and understanding of US and international medical device regulations, standards and guidance documents.
•    Project Management skills and experience.

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

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.