Sr Applications Quality Engineer

Job Title

Responsible for development, implementation, and maintenance of Quality System applications and data visualization tools. This role will strategically align with business objectives to develop, implement, and optimize digital solutions that enhance operational excellence across quality and manufacturing processes.

The role involves collaborating with cross-functional teams to plan, execute, and document CSV efforts, monitor validated systems, conduct periodic reviews, and manage related investigations. This role will ensure system support and maintenance of applicable business applications and data visualization tools are appropriately established. You will work with our business customers to ensure key technologies are delivering required value to the organization.

• Ensure application support and management by establishing processes to manage user accounts, permissions, and security policies.
• Ensure appropriate level of technical assistance is available to users.
• Ensure process is established to troubleshoot issues and conduct training on new features and system use.
• Manage the handling of incidents until they are fully resolved, with a detailed analysis of the underlying causes provided.
• Monitor and maintain these technologies at optimal performance levels.
• Responsible for gathering requirements and analyzing processes in order to recommend new technologies or improvements existing to quality system applications or data visualization tools.
• Interpret business requirements to functional designs. Configure and/or partner with external design engineers to configure applications or data visualization tools which align with business requirements.
• Acts as the principal designer for major systems and their subsystems.
• Build and maintain multiple DEV, QA and production environments
• Collaborate with key stakeholder on system upgrades and enhancements. Provide input to create a compelling roadmap for new technology and system upgrades.
• Create and maintain robust and validated processes for making changes.
• Lead in the planning, development, and implementation of computer systems validation documentation and ensure compliance with required GxP and 21 CFR Part 11 regulations.
• Provide input in creation and/or review of internal operating procedures.
• Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to industry standards and federal regulations.
• Provide support for the Quality Assurance/Operations Departments and to other company departments as directed by Quality Systems Management.
• Serve as the CSV representative during regulatory inspections.
• Own the full project lifecycle for software application deployments — from initial scoping through production release — serving as the technical lead and primary escalation point for cross-functional teams.
• Drive the planning, testing, and implementation of new software capabilities and operational improvements, bringing innovative approaches to complex deployment challenges at the division or business unit level.
• Manage project scope, budgets, and delivery timelines with rigor, ensuring all milestones are met across directly managed and matrixed teams.
• Hold accountability for the successful, on-time completion of every task and project under your purview, proactively identifying risks and resolving blockers before they impact delivery.

• Bachelor's Degree in Computer Science and/or Life Sciences
• 5+ years of computer software support and/or related experience
• 5+ Experience in Quality Assurance within medical device/pharma environment and/or related field.
• Drivers License Upon Hire

Technical & Functional Skills

• Must be proficient in MS Word, Excel, and PowerPoint software programs.
• Must have excellent verbal and written communication skills and leadership skills.
• Ability to work with company staff and communicate effectively throughout the organization is essential.
• Familiar with industry standards and Federal Regulations.
• Strong understanding of industry standards and best practices for computer computer validation and…