INGENYX - Quality Systems and Digital Engineer

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 in partnership with IT and system owners.
•Support vendor assessments and ongoing oversight of third-party Quality system providers.
•Support data migration, system upgrades, system retirement, archival, and record retention activities.
•Monitor system performance and identify opportunities for improved usability, efficiency, compliance, and standardization.
•Support investigation and remediation of system-related audit findings, data integrity concerns, and compliance gaps.
•Promote standardized digital Quality processes and sharing of best practices across sites and functions.

Compliance & Governance
•Support compliance with applicable Quality System, electronic record, electronic signature, and computerized system requirements.
•Support compliance with 21 CFR Part 11, FDA QMSR, ISO 13485, and applicable internal procedures.
•Apply data integrity principles throughout the computerized system lifecycle.
•Maintain validation and system lifecycle documentation in an audit- and inspection-ready state.
•Support internal audits, customer audits, and regulatory inspections involving Quality computerized systems.
•Partner with Quality Systems, IT, and process owners to maintain appropriate controls for electronic records, electronic signatures, audit trails, security, access, backup, recovery, and data retention.
•Support development and continuous improvement of CSV/CSA, digital Quality, data governance, and system lifecycle procedures and practices.

Education / Experience Requirements

Required
• Bachelor’s degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, Data Analytics, or a related technical discipline.
• 3+ years of experience in Quality Systems, Quality Engineering, computerized system validation, digital Quality, business systems, or a related function within a regulated industry.
• Working knowledge of 21 CFR Part 11, FDA QMSR, and ISO 13485.
• Familiarity with Computer Software Assurance (CSA), CSV, GAMP 5, and risk-based validation principles.
• Experience supporting computerized systems within a Quality or regulated environment.
• Experience with system requirements, testing, validation, change control, or system implementation.
• Working knowledge of Quality Management Systems and regulated business processes.
• Strong analytical skills with experience analyzing and presenting Quality or operational data.
• Ability to translate business and Quality requirements into system requirements and practical solutions.
• Strong technical writing, documentation, problem-solving, and organizational skills.
• Ability to work effectively across Quality, IT, Operations, business functions, and external vendors.
Preferred
• Medical device industry experience.
• Experience with eQMS and/or ERP Quality functionality.
• Experience with CAPA, nonconformance, document control, training, audit, supplier quality, complaint, or change management applications.
• Experience developing Quality dashboards, metrics, automated reporting, or data visualization.
• Experience with cloud/SaaS applications and vendor-managed systems.
• Familiarity with data integrity, electronic records, electronic signatures, audit trails, and computerized system lifecycle management.
• Experience supporting regulatory inspections or customer audits involving computerized systems.

Specialized Skills / Other Requirements

The pay range for this position at the commencement of employment is expected to be between $87,400 and $109,200; however, the 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, the 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.