INGENYX- Senior Sterility Manager (Remote- US

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Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.

Ingenyx 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 ISO
  14644 standards (Bioburden testing, Environmental monitoring (EM), OOS/OOT, etc)
• Sets technical direction for SA strategy development in collaboration with business partners.
  • Sterilization (EO, Gamma, E-beam)
  • Microbiology and contamination control
  • Biocompatibility and toxicology
• Oversee toxicological risk assessments, including:
  • Extractables & leachables evaluation
  • EO residuals toxicological impacts
• Lead the biocompatibility program with applicable standards, including:
  • Biological risk assessments (BRA)
  • Test strategy development
  • 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,…