Quality Engineer-Sr. Applications

Job Description

Presented by Procom for our client, a leading organization within a highly regulated industry environment.

We are seeking an experienced Quality Engineer- Application Analyst responsible for the development, implementation, support, and maintenance of Quality Systems applications and data visualization tools. This individual will play a key role in supporting operational excellence initiatives across quality and manufacturing environments by optimizing digital solutions, supporting validated systems, and ensuring compliance with applicable regulatory standards.

The ideal candidate will collaborate closely with cross-functional stakeholders to support system enhancements, validation activities, troubleshooting efforts, reporting capabilities, and long-term technology roadmaps.

Education

• Bachelor’s Degree in Computer Science, Life Sciences, or related field preferred

Required Experience

• 5+ years of experience supporting computer software systems, business applications, or related technologies
• Experience supporting regulated environments and validated systems
• Strong understanding of software validation principles and quality system processes

Key Responsibilities

Application Support & Administration
• Manage application support processes including user accounts, permissions, and security controls
• Provide technical assistance and troubleshooting support to end users
• Coordinate issue resolution activities and perform root cause analysis for incidents
• Conduct user training related to system functionality and new features
• Monitor and maintain applications to ensure optimal system performance

Application Development & Configuration
• Gather business requirements and evaluate opportunities for system enhancements or new technologies
• Translate business requirements into functional designs and technical solutions
• Configure applications and collaborate with technical teams or third-party partners on system development efforts
• Support and maintain development, QA, and production environments

System Enhancements & Continuous Improvement
• Partner with stakeholders on system upgrades, enhancements, and technology roadmap initiatives
• Develop and maintain validated change management processes
• Identify opportunities to improve system efficiency, reporting, and operational effectiveness

Computer System Validation (CSV)
• Lead planning, documentation, and execution of computer systems validation activities
• Ensure compliance with GxP requirements, 21 CFR Part 11, and applicable regulatory standards
• Support periodic reviews and validation lifecycle management activities

Compliance & Quality Support
• Assist with maintaining compliance to quality policies, procedures, and regulatory requirements
• Support Quality Assurance, Operations, and related business functions as needed
• Serve as a CSV representative during audits and regulatory inspections

Project Leadership
• Lead or support technical projects involving system implementations, upgrades, or process improvements
• Coordinate project activities to ensure completion within scope, budget, and timeline expectations
• Support cross-functional collaboration across business and technical teams

Documentation & Training
• Assist with SOP creation, review, and maintenance activities
• Mentor junior team members on validation processes, documentation, and system support practices
• Build strong working relationships with internal stakeholders and end users

Required Technical Skills

• Proficiency with Microsoft Word, Excel, and PowerPoint
• Excellent verbal and written communication skills
• Strong organizational, analytical, and problem-solving abilities
• Familiarity with industry regulations and compliance standards
• Strong understanding of software validation frameworks including GAMP 5, 21 CFR Part 11, Annex 11, and related standards
• Ability to communicate effectively across technical and non-technical teams

Preferred Qualifications

• Experience configuring enterprise business applications
• Experience with eQMS platforms such as MasterControl, SmartSolve, or similar systems
• Experience supporting quality systems, manufacturing systems, or regulated operational environments
• Strong technical writing skills and documentation experience

Additional Information

• Hybrid work schedule available
• Experience working in highly regulated environments is strongly preferred
• Candidates with a blend of technical expertise, compliance knowledge, and stakeholder engagement experience are encouraged to apply