Quality Systems and Digital Engineer

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Take ownership of CSV/CSA activities for eQMS platforms, ERP Quality functionalities, and other computerized applications that support Quality processes.

• Create risk-based validation strategies and ensure the maintenance of validation documentation.

• Coordinate and conduct testing for new systems, configurations, integrations, enhancements, upgrades, and significant modifications.

• Keep systems in a validated condition throughout their entire lifecycle.

• Assist in the investigation and resolution of validation deviations and system-related quality concerns.

• Act as a Subject Matter Expert (SME) and super-user for eQMS, ERP Quality modules, and other Quality applications.

• Convert business and regulatory requirements into digital workflows and system specifications.

• Aid in the configuration, implementation, testing, deployment, and enhancement of Quality system functionalities.

• Streamline, standardize, and automate Quality processes.

• Transform manual, paper-based, or spreadsheet-driven processes into controlled electronic workflows.

• Develop process maps, functional requirements, user requirements, and workflow designs.

• Facilitate integrations among Quality applications and ERP, document management, training, manufacturing, supplier, and other business systems.

• Collaborate with IT and software vendors to resolve issues and coordinate improvements.

• Support user acceptance testing, deployment, training, and the adoption of digital Quality processes.

• Establish and maintain Quality metrics, dashboards, and reporting tools.

• Analyze Quality data to uncover trends, risks, recurring issues, and opportunities for improvement.

• Assist in reporting and trending for CAPA, nonconformance, complaints, audits, suppliers, inspections, and training.

• Define KPIs and measures of process effectiveness in collaboration with process owners.

• Automate regular Quality reports and assist in Quality Management Review and leadership reporting.

• Maintain computerized Quality system inventories, lifecycle information, periodic reviews, and change impact assessments.

• Support user access reviews, vendor evaluations, data migration, upgrades, retirement, archival, and record retention.

• Aid in resolving system-related audit findings, data integrity issues, and compliance gaps.

• Ensure compliance with 21 CFR Part 11, FDA QMSR, ISO 13485, electronic records, electronic signatures, and computerized system requirements.

• Assist with internal audits, customer audits, and regulatory inspections involving Quality computerized systems.

⛳️ Requirements

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, Data Analytics, or a related technical field.

• At least 3 years of experience in Quality Systems, Quality Engineering, computerized system validation, digital Quality, business systems, or a related role in a regulated industry.

• Proficient knowledge of 21 CFR Part 11, FDA QMSR, and ISO 13485.

• Familiar with Computer Software Assurance (CSA), CSV, GAMP 5, and principles of risk-based validation.

• Experience in supporting computerized systems in a Quality or regulated environment.

• Knowledge of system requirements, testing, validation, change control, or system implementation.

• Working knowledge of Quality Management Systems and regulated business processes.

• Strong analytical abilities with experience in analyzing and presenting Quality or operational data.

• Capability to translate business and Quality needs into system specifications and practical solutions.

• Excellent technical writing, documentation, problem-solving, and organizational skills.

• Ability to work efficiently across Quality, IT, Operations, business functions, and with external vendors.

• Candidates should be located remotely in the US, preferably in the Eastern or Central Time Zones.

• Preferred: Experience in the medical device industry.

• Preferred: Knowledge of eQMS and/or ERP Quality functionalities.

• Preferred: Familiarity with CAPA, nonconformance, document control, training, audit, supplier quality, complaint, or change management applications.

• Preferred: Experience in developing Quality dashboards, metrics, automated reporting, or data visualization.

• Preferred: Knowledge of cloud/SaaS applications and vendor-managed systems.

• Preferred: Familiarity with data integrity, electronic records, electronic signatures, audit trails, and computerized system lifecycle management.

• Preferred: Experience supporting regulatory inspections or customer audits related to computerized systems.

🏝️ Benefits

• Medical insurance

• Prescription drug insurance

• Dental insurance

• Vision insurance

• Flexible spending accounts

• Participation in 401(k) savings plan

• Paid time off (PTO)

• Short- and long-term disability

• Parental leave