INGENYX - Quality Systems and Digital Engineer (Remote, MA, US)

About this role

Expected Travel: None
Requisition ID: 14577

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.
For more information, please visit

Position Summary

We are seeking a Quality Systems & Digital Quality Engineer to support the digital transformation, validation, administration, and continuous improvement of Quality Management System (QMS) technologies and applications across a global medical device organization.

Reporting to the Quality Systems Manager, this role serves as the Quality functional and technical liaison between Quality process owners, IT, business stakeholders, and software vendors. The position is responsible for Computer System Validation/Computer Software Assurance (CSV/CSA), digital Quality workflows, Quality data and analytics, and ongoing lifecycle management of computerized Quality systems.
The role will help ensure Quality applications are compliant, effective, appropriately validated, and designed to support efficient and standardized Quality processes.

**Candidates must be based remotely in the US, with a strong preference for Eastern and Central Time Zones**

Principal Responsibilities

CSV / Computer Software Assurance – Approximately 30%
•Own CSV/CSA activities for eQMS platforms, ERP Quality functionality, and other computerized applications supporting Quality processes.
•Develop risk-based validation strategies appropriate to the system's intended use, functionality, and potential impact on product quality and patient safety.
•Develop, review, and maintain validation documentation, including requirements, risk assessments, validation plans, test protocols/scripts, traceability, deviations, and validation summary documentation.
•Coordinate and execute testing for new systems, configurations, integrations, enhancements, upgrades, and significant changes.
•Ensure business and Quality requirements are appropriately traced to testing and release documentation.
•Assess computerized system changes for validation impact and determine appropriate testing and documentation requirements.
•Maintain systems in a validated state throughout their lifecycle.
•Support investigation and resolution of validation deviations and system-related quality issues.
•Apply risk-based CSA principles to streamline validation activities while maintaining appropriate compliance and objective evidence.
•Support audit and regulatory inspection readiness for computerized system validation records.

QMS Technology & Digitalization – Approximately 30%
•Serve as a Quality functional SME and super-user for eQMS, ERP Quality modules, and other Quality applications.
•Partner with Quality process owners to translate business and regulatory requirements into effective digital workflows and system requirements.
•Support configuration, implementation, testing, deployment, and enhancement of Quality system functionality.
•Identify opportunities to simplify, standardize, and automate Quality processes.
•Support conversion of manual, paper-based, or spreadsheet-driven Quality processes into controlled electronic workflows.
•Develop process maps, functional requirements, user requirements, and workflow designs for Quality applications.
•Support integration between Quality applications and ERP, document management, training, manufacturing, supplier, and other business systems.
•Partner with IT and software vendors to troubleshoot system issues and coordinate enhancements.
•Support user acceptance testing and deployment of new or revised functionality.
•Develop and maintain user guides, work instructions, and system/process documentation.
•Support training and adoption of new digital Quality processes and tools.

Quality Data & Analytics – Approximately 20%
•Develop and maintain Quality metrics, dashboards, and reporting tools.
•Analyze Quality data to identify trends, risks, recurring issues, and improvement opportunities.
•Support reporting and trending for CAPA, nonconformance, complaints, audits, suppliers, inspection, training, and other Quality processes.
•Partner with process owners to establish meaningful KPIs and measures of process effectiveness.
•Improve standardization, consistency, and integrity of Quality data across systems.
•Identify opportunities to automate recurring Quality reports and reduce manual data manipulation.
•Support Quality Management Review and leadership reporting.
•Perform data analysis to support continuous improvement, CAPA, project activities, and Quality objectives.
•Support development of data visualization and reporting capabilities that enable timely, risk-based decision-making.

Principal Responsibilities Continued

System Lifecycle & Continuous Improvement – Approximately 20%
•Maintain or support the inventory of computerized systems used within the Quality organization.
•Maintain system information, including intended use, ownership, Quality/regulatory impact, validation status, interfaces, and lifecycle status.
•Coordinate periodic reviews of validated Quality systems.
•Support system and change impact assessments.
•Support Quality aspects of user access, roles, permissions, and periodic access reviews…