Templeton, Massachusetts, United States · On-site
$152k–$229k/yr
Expected Travel: Up to 25% Requisition ID: 13997 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 ou…
Skills: Sterility Assurance, Microbiology, Biocompatibility, Toxicology, EO Sterilization
Rostock, Mecklenburg-Vorpommern, Germany · On-site
Reisetätigkeit: Keine Stellenanforderungsnummer: 13918 Über Teleflex Incorporated Als globaler Anbieter medizinischer Technologien verfolgt Teleflex das Ziel, die Gesundheit und Lebensqualität der Menschen zu verbessern.…
Skills: Team Leadership, Quality Assurance, SAP, Cleanroom Operations, Microscopic Inspection
Templeton, Massachusetts, United States · Remote OK
$152k–$229k/yr
Expected Travel: Up to 25% Requisition ID: 13997 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 ou…
Skills: Sterility Assurance, Microbiology, Biocompatibility, Toxicology, EO Sterilization
Philadelphia, Pennsylvania, United States · Remote OK
$93k–$139k/yr
Expected Travel: Up to 50% Requisition ID: 13840 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 ou…
Skills: Clinical Education, Product Evaluation, Interventional Cardiology, Patient Care, Curriculum Creation
Minneapolis, Minnesota, United States · Remote OK
$93k–$139k/yr
Expected Travel: Up to 50% Requisition ID: 13840 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 ou…
Skills: Clinical Education, Product Evaluation, Medical Device Training, Evidence-Based Consultation, Interventional Cardiology
Maple Grove, Minnesota, United States · On-site
$87k–$131k/yr
Expected Travel: Up to 10% Requisition ID: 13978 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 ou…
Skills: EHS Management, Risk Assessment, Regulatory Compliance, Incident Investigation, Root Cause Analysis
Athlone, Leinster, Ireland · Hybrid
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 he…
Skills: French Fluency, English Fluency, Customer Service, SAP, Microsoft Office
Athlone, Leinster, Ireland · Hybrid
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 he…
Skills: Customer Service, Order Processing, SAP SD, French Fluency, Account Management
Berlin, Germany · Remote OK
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 he…
Skills: Sales, Customer Relationship Management, Medical Device Sales, Product Presentation, Clinical Training
Athlone, Leinster, Ireland · Hybrid
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 he…
Skills: Portfolio Coordination, Strategic Operations, Stakeholder Management, Project Management, Data Governance
Wayne, Pennsylvania, United States · On-site
Expected Travel: None Requisition ID: 13999 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 vis…
Skills: Consolidated Financial Statements, Technical Accounting, Foreign Currency, Equity Transactions, Balance Sheet Roll-forwards
Kamunting, Perak, Malaysia · On-site
Expected Travel: None Requisition ID: 12804 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 vis…
Skills: Process Engineering, Medical Technology, Quality Improvement, Product Fulfilment
Durham, North Carolina, United States · Remote OK
$110k–$120k/yr
Expected Travel: Up to 50% Requisition ID: 13847 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 ou…
Skills: Clinical Education, Product Evaluation, Evidence-based Consultation, Medical Device Training, Interventional Radiology
Philadelphia, Pennsylvania, United States · Remote OK
$110k–$120k/yr
Expected Travel: Up to 50% Requisition ID: 13847 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 ou…
Skills: Clinical Education, Product Evaluation, Medical Device Training, Evidence-Based Consultation, Interventional Radiology
Kokkola, Central Ostrobothnia, Finland · On-site
Expected Travel: None Requisition ID: 13975 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 vis…
Skills: Injection Molding, LSR Molding, Scientific Systematic Molding, Process Validation, Root Cause Analysis
Rostock, Mecklenburg-Vorpommern, Germany · On-site
Reisetätigkeit: Keine Stellenanforderungsnummer: 13925 Über Teleflex Incorporated Als globaler Anbieter medizinischer Technologien verfolgt Teleflex das Ziel, die Gesundheit und Lebensqualität der Menschen zu verbessern.…
Skills: CAD Construction, Prototype Construction, Literature Research, MS Office, Analytical Thinking
Houston, Texas, United States · Remote OK
Expected Travel: More than 50% Requisition ID: 13965 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. Throug…
Skills: Medical Device Sales, Urology Knowledge, KOL Relationship Management, Operating Room Experience, Sales Forecasting
Olive Branch, Mississippi, United States · On-site
Expected Travel: Up to 10% Requisition ID: 13894 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 ou…
Skills: Operational Leadership, Distribution Center Management, People Development, KPI Management, Continuous Improvement
Bülach, Zurich, Switzerland · On-site
Expected Travel: None Requisition ID: 13863 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 vis…
Skills: Contract Negotiation, Budget Management, Clinical Trial Agreements, Financial Tracking, Regulatory Compliance
Olive Branch, Mississippi, United States · On-site
Expected Travel: Up to 10% Requisition ID: 13894 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 ou…
Skills: Distribution Center Operations, People Leadership, WMS, KPI Management, Continuous Improvement
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This role provides strategic leadership and technical expertise in sterility assurance, microbiology, biocompatibility, and toxicology for medical device products. The manager is responsible for ensuring compliant quality systems, validating sterilization processes, and managing cleanroom environments to meet ISO standards.
Requires a bachelor's degree in a technical field with at least 15 years of experience in sterilization or medical device RAQA/Engineering, including 5 years of managerial experience. Expertise in ISO standards (11135, 11137, 11138, 14644, 10993) and practical experience with various sterilization methods is essential.
Expected Travel: Up to 25%
Requisition ID: 13997
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.
OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
This position is responsible for Sterility Assurance. Sterility Assurance includes sterilization, environmental control, microbiological methods and processes, biocompatibility, and toxicology assessments and testing related to products either designed and/or manufactured by OEM. The role requires a senior strategic leader and technical expert who can manage a broad set of activities as described below.
• Provides expert technical opinion, advice, and recommendations to the President of OEM regarding Sterility Assurance, Microbiology, Biocompatibility, and Toxicology.
• Responsible for ensuring compliant quality systems for Sterility Assurance, Microbiology, Biocompatibility, and Toxicology, meeting the applicable standards and OEM business needs
• Responsible for ensuring all technical aspects for establishing, validating, maintaining, and dispositioning sterilization processes - EO (cycle development, residuals, parametric release) and Gamma & E-beam (dose setting, auditing, dose mapping) are delivered per the applicable standards for products at the applicable facilities.
• Ensure sterilization failures are investigated and implement robust CAPAs.
• Leading all technical aspects of establishing, validating, maintaining, and dispositioning cleanroom environment to meet ISO14644 standards (Bioburden testing, Environmental monitoring (EM), OOS/OOT, etc)
• Sets technical direction for SA strategy development in collaboration with business partners.
o Sterilization (EO, Gamma, E-beam)
o Microbiology and contamination control
o Biocompatibility and toxicology
• Oversee toxicological risk assessments, including:
o Extractables & leachables evaluation
o EO residuals toxicological impacts
• Lead the biocompatibility program with applicable standards, including:
o Biological risk assessments (BRA)
o Test strategy development
o Justification of test requirements
• Manages and supports Quality Improvement projects in Sterility Assurance. Constantly delivers improved value for all stakeholders by driving and developing a culture of excellence through continuous improvement.
• Supports Sterilization Supplier Quality Management and partnership with the Operations Procurement team.
• Support supplier audits and ensure compliance with quality agreements.
• Manages relationships with many stakeholders in different functions and locations. Provides leadership and direction in Sterilization methods to Development, Operations, QA, Procurement and other functions for New Product Development, and product, process and vendor changes.
• Actively drives key talent development through coaching, mentoring, development assignments and other formal and informal actions and systems.
• Serves as strategic member of the QARA team.
• Ensures the focus of every employee within the Sterility Assurance function is on delivering the highest product and service quality standards to all our customers and their patients in a consistent manner and that the systems necessary to do so are in place.
• Defines and recommends goals and objectives in Sterility Assurance. Develops specific short-term and long-term plans and programs, together with supporting budgets.
• Ensures that necessary legal, regulatory and corporate compliance systems are in place and adhered to.
• Provide other departmental support as requested by immediate supervisor.
• Adhere to and ensure the compliance of OEM Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
• Minimum education bachelor’s degree in a technical field, advanced degree preferred.
• Minimum 15 years’ experience in a sterilization-related field, the medical device industry in RAQA / Engineering / Manufacturing/environment, with 5 years of managerial experience.
• Extensive knowledge and understanding of ISO 11135, 11137, 11138,14644 and 10993 requirements along with expertise in achieving compliance.
• Proven audit experience for various regulatory bodies/agencies.
• Experience in a matrix management organization is a must.
• Excellent Communication skills with the ability to articulate technical information in a clear and concise manner.
• Practical experience with aspectic sampling, EO, gamma/ E.Beam Sterilization methods essential, steam, filtration sterilization, and aseptic fill processes desirable.
All people managers are responsible for the following:
• Organization Capability - Building organizational capability with a focus on developing the skills, knowledge, and potential of both individuals and teams.
• Cross-functional and Customer Alignment - Building cross-functional and Customer relationships and alignment is essential to driving coordinated, organization-wide success. Leaders must foster open communication, trust, and mutual respect. .
• Continuous Improvement - Fostering a culture where learning, innovation, and adaptability are part of everyday work. Use of data and feedback to inform decisions and to recognize both progress and lessons learned.
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The pay range for this position at commencement of employment is expected to be between $152,000 – $229,000; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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.
Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [email protected].
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2026 Teleflex Incorporated. All rights reserved.
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. At Teleflex, we are empowering the future of healthcare. Headquartered in Wayne, PA, Teleflex employs over 14,000 people worldwide and serves healthcare providers in more than 150 countries.
Offices: 550 E. Swedesford Road, Suite 400, Wayne, PA 19087, US · 3015 Carrington Mill Blvd, Morrisville, NC 27560, US · IDA Business and Technology Park, Dublin Rd, Athlone, Co Westmeath, IE · 6 Battery Road, #07-02, Singapore, 049909, SG
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. At Teleflex, we are empowering the future of healthcare. Headquartered in Wayne, PA, Teleflex employs over 14,000 people worldwide and serves healthcare providers in more than 150 countries.
Offices: 550 E. Swedesford Road, Suite 400, Wayne, PA 19087, US · 3015 Carrington Mill Blvd, Morrisville, NC 27560, US · IDA Business and Technology Park, Dublin Rd, Athlone, Co Westmeath, IE · 6 Battery Road, #07-02, Singapore, 049909, SG
