Puesto, ciudad o estado.

Hace 5 días

Associate Scientist, Sterility Assurance

$30,000 - $35,000 Mensual

TELEFLEX en
Company logo

Hace 5 días

Associate Scientist, Sterility Assurance

$30,000 - $35,000 Mensual

TELEFLEX

en

Company logo

Sobre el empleo

Categoría: Ingeniería
Subcategoría: Ingeniería química
Educación mínima requerida: Universitario sin titulo

Detalles

Contratación:Permanente
Espacio de trabajo:Híbrido

Beneficios

  • Prestaciones superiores a las de la ley
  • Fondo de ahorro
  • Vales de despensa

Descripción

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.


Latin America - The Latin America Region of Teleflex is headquartered in Morrisville, North Carolina, and supports our customers, distributors, sales managers and specialists in Mexico, Brazil, Colombia, Chile, Argentina and Puerto Rico. The Latin America Region sells a broad spectrum of medical devices and related products in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. As Teleflex grows and expands its portfolio, we will continue to grow our presence in Latin America. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.


Position Summary


The Associate Scientist will support sterilization/microbiological methods and process controls related to purchased products designed by Teleflex Medical and manufactured by contractors, products designed and manufactured by Teleflex Medical and/or purchased products labeled and sold by Teleflex Medical. Review and approve sterilization cycle development, process validations, equivalency reviews, alternate sterilization methods, facility environmental controls and product microbiological controls (as needed).



Principal Responsibilities


  • Collaborate with Global Procurement and the site/business unit quality team(s) to provide the appropriate sterility assurance support for purchased finished good (PFG's) and sterilization suppliers.
  • Serve as a sterilization subject matter expert in Purchasing & Supplier Controls.
  • Prepare and execute sterilization validations and test protocols/reports for all internal and external Teleflex Medical sterilization facilities (as needed).
  • Evaluate impact/efficacy of existing sterilization methods on new products or new product designs. Act as sterilization expert for teams bringing new products to market.
  • Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods.
  • Provide support for sterilization practices to ensure all products and processes comply with the regulatory standards.
  • Provide input to creating strategies to assure compliance to regulatory standards regarding sterilization for Teleflex Medical products.
  • Provide sterilization expertise during internal and external audits.
  • Provide support to ensure contract manufacturers use consistent and compliant methods for the following: EO Residuals, dose audits, dose setting, dose mappings, dose augmentations, bioburden monitoring, environmental monitoring, cleanroom practices, and bacterial endotoxin testing.
  • Provide sterilization, microbiological and environmental control expertise during supplier quality audits of critical suppliers/vendors (as needed).
  • Provide expertise in support of process deviations.
  • Support developing, implementing, and executing proactive supplier risk profiling to identify and eliminate potential supplier risks.
  • Support sterilization supplier facility compliance audits to ensure sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
  • Support developing and implementing management reporting tools for in-crisis suppliers and proactive risk monitoring.
  • Perform miscellaneous projects and duties at the direction of Sterility Assurance Management.
  • Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.



Education / Experience Requirements


  • English proficiency is a Must - written and verbal skills
  • B.S. Degree in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background.
  • Msc. Qualification preferable but not essential.
  • Experience of 3 to 5 years of experience in sterilization of medical devices.



Salary / Benefits


  • Hybrid Position (Home Office + On Site) Office near Metrobus Napoles / Monday - Friday 8am to 5pm
  • $30,000 to $35,000 MXN Monthly
  • Permanent Contract
  • Superior Law Benefits
  • 30 days Year End Bonus
  • Medical Insurance
  • 13% Saving Fund
  • Grocery Vouchers


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.


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 US and/or other countries.


© 2024 Teleflex Incorporated. All rights reserved.

ID: 18451570