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Form of workExpected Travel: None
Requisition ID: 9889
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.
Responsible for the environmental/microbial control in the Teleflex manufacturing facilities. Complete planning, coordination and execution of deliverables related to environmental control, microbial control, sterilization qualifications and cleaning/disinfection control of manufacturing areas.
Performs the environmental and microbial control monitoring.
Performs the water sampling and monitoring.
Coordinates the sampling of finished goods for bioburden and dose audit testing.
Record and analyze the results of the environmental, water, product bioburden and dose audit testing.
Maintains database with all the environmental, bioburden, dose audit and water results.
Tracks and trends environmental, bioburden, dose audit and water results in accordance with the requirements and document in technical reports.
Participates in the initiation and implementation of corrective actions when the results exceed the
established limits.
Perform investigations and provide technical support for nonconforming events related to microbial or environmental control.
Be the main contact with the internal / eternal laboratory for the microbiological monitoring.
Supports training of all staff in basic microbiology and recommended hygienic practices inside the controlled areas as required.
Support sustaining sterilization special projects as required.
Coordinate the calibrations when applicable.
Performs any activity assigned by their manager.
Coordination and preparation of EO process challenge devices (PCDs).
Bachelor's Degree in Biology, Chemistry, Microbiology or other related science or engineering field.
0 - 2 years of experience in environmental control of controlled areas or similar position.
1 year experience in medical device industry (preferably).
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.
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Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
