INGENYX - Quality Systems and Digital Engineer

Teleflex•Templeton, MA

5d•$87,400 - $109,200•Remote

About The Position

Ingenyx is seeking a Quality Systems & Digital Quality Engineer to support the digital transformation, validation, administration, and continuous improvement of Quality Management System 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 among Quality process owners, IT, business stakeholders, and software vendors. The position covers CSV/CSA, digital Quality workflows, Quality data and analytics, and the lifecycle management of computerized Quality systems, helping ensure applications are compliant, effective, appropriately validated, and designed to support efficient, standardized Quality processes. Candidates must be based remotely in the US; Eastern and Central Time Zones are strongly preferred. The role owns or supports risk-based computer system validation and assurance for eQMS platforms, ERP Quality functionality, and other computerized applications; develops and maintains validation documentation; coordinates testing and change impact assessments; and supports audit and inspection readiness. It also serves as a Quality subject matter expert and super-user for Quality applications, partnering with process owners, IT, and vendors to translate requirements into digital workflows, implement and test system functionality, troubleshoot issues, and support user adoption. The engineer develops and maintains Quality metrics, dashboards, and reports; analyzes data to identify trends, risks, and improvement opportunities; and supports Quality Management Review and leadership reporting. The role also supports computerized-system inventories, periodic reviews, access controls, vendor oversight, data migration, upgrades, retirement, archival, record retention, and remediation of system-related findings and data-integrity concerns. The position supports compliance with applicable Quality System, electronic record, electronic signature, and computerized-system requirements, including 21 CFR Part 11, FDA QMSR, and ISO 13485. It helps maintain lifecycle documentation and appropriate controls for electronic records, signatures, audit trails, security, access, backup, recovery, and retention, and contributes to continuous improvement of CSV/CSA, digital Quality, data governance, and lifecycle practices.

Requirements

Bachelor’s degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, Data Analytics, or a related technical discipline.
At least 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 and 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.
Must be based remotely in the United States.

Nice To Haves

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.
Residence in the Eastern or Central Time Zone is strongly preferred.

Responsibilities

Own CSV/CSA activities for eQMS platforms, ERP Quality functionality, and other computerized applications supporting Quality processes.
Develop risk-based validation strategies and validation documentation, including requirements, risk assessments, plans, test protocols, traceability, deviations, and validation summaries.
Coordinate and execute testing for new systems, configurations, integrations, enhancements, upgrades, and significant changes; assess change impact and maintain systems in a validated state.
Support resolution of validation deviations and system-related Quality issues, and maintain audit- and inspection-ready validation records.
Serve as a Quality functional subject matter expert and super-user for eQMS, ERP Quality modules, and other Quality applications.
Translate business and regulatory requirements into system requirements, digital workflows, process maps, functional requirements, user requirements, and workflow designs.
Support configuration, implementation, testing, deployment, integration, and enhancement of Quality system functionality.
Identify opportunities to simplify, standardize, and automate Quality processes, including converting manual or spreadsheet-based processes into controlled electronic workflows.
Partner with IT and software vendors to troubleshoot system issues and coordinate enhancements; support user acceptance testing and deployment.
Develop and maintain user guides, work instructions, and system/process documentation; support training and adoption of digital Quality processes and tools.
Develop and maintain Quality metrics, dashboards, and reporting tools; analyze 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 KPIs and measures of process effectiveness, improve Quality data integrity and standardization, and automate recurring reports.
Support Quality Management Review, leadership reporting, continuous improvement, CAPA, project activities, and risk-based decision-making through data analysis and visualization.
Maintain or support an inventory of computerized systems used within the Quality organization and related information, including intended use, ownership, impact, validation status, interfaces, and lifecycle status.
Coordinate periodic reviews and support system and change impact assessments, user access controls, roles, permissions, and periodic access reviews in partnership with IT and system owners.
Support vendor assessments and oversight, data migration, upgrades, system retirement, archival, and record retention activities.
Monitor system performance and support investigation and remediation of audit findings, data integrity concerns, and compliance gaps.
Promote standardized digital Quality processes and sharing of best practices across sites and functions.
Support compliance with applicable Quality System, electronic record, electronic signature, and computerized-system requirements, including 21 CFR Part 11, FDA QMSR, and ISO 13485.
Apply data integrity principles and support controls for electronic records, electronic signatures, audit trails, security, access, backup, recovery, and data retention.
Support internal audits, customer audits, and regulatory inspections involving Quality computerized systems.
Support development and continuous improvement of CSV/CSA, digital Quality, data governance, and system lifecycle procedures and practices.