Quality Systems Engineer

Summary

The Quality Systems Engineer (Automation & AI Focus) is responsible for designing, building, and optimizing technology-enabled quality systems across In-Clinic and Pharmacy Quality & Regulatory Operations. This role goes beyond traditional quality engineering by translating quality processes into structured, automated workflows and system logic. The position leverages AI tools, low‑code platforms, and system integrations to drive scalable, data-driven execution of core quality processes (e.g., Complaint → Nonconformance → CAPA).

Working closely with Quality, IT, and Operations, this role serves as a builder of digital quality infrastructure, ensuring compliance while enabling speed, consistency, and operational clarity. This role reports to the Quality and Regulatory Systems Manager.

Automation & System Design (Core Focus)

Design, build, and deploy automated workflows and decision logic across quality processes using low‑code platforms (e.g., Power Automate, Salesforce Flow) and AI-assisted tools. Translate ambiguous or manual processes into structured, deterministic workflows that drive consistent execution.

Develop automation solutions for:

• Complaint intake, triage, and escalation
• Nonconformance and CAPA workflows
• Supplier quality monitoring and triggers
• Recall and traceability processes

Integrate systems (Salesforce, QMS, data platforms) to enable end-to-end process visibility and control.

Technology & Data Utilization

Leverage AI tools (e.g., Copilot, ChatGPT, Claude) to:

• Accelerate analysis and root‑cause identification
• Improve workflow efficiency
• Support decision‑making frameworks

Build and maintain dashboards, automated reporting, and data pipelines to monitor quality signals and trends. Identify and prioritize opportunities to eliminate manual, repetitive, or error‑prone activities through automation.

Quality Systems Ownership

Administer and enhance QMS and related platforms to ensure:

• Data integrity (ALCOA+)
• System reliability
• Regulatory compliance

Implement system-based controls that reduce variability and enforce process consistency.

Quality Operations Enablement

Apply engineering and system-based solutions to improve:

• Complaint investigations
• Nonconformance management
• CAPA effectiveness and timeliness

Drive improvements in:

• Recall systems and traceability
• Supplier quality systems and performance monitoring
• DSCSA-related data exchange and system controls
• In-Clinic product onboarding workflows

Collaboration & Continuous Improvement

Partner with Quality, IT, Supply Chain, and Operations to design scalable, system-enabled solutions. Provide guidance and training on automation tools, workflows, and system capabilities. Support audits, inspections, and system validations with a focus on system integrity and traceability. Continuously evaluate emerging technologies and apply them to improve quality system performance.

• Hands‑on experience building automated workflows using low‑code/no‑code platforms (e.g., Power Automate, Salesforce Flow) or equivalent tools.
• Demonstrated ability to translate processes into structured system logic and decision frameworks.
• Experience leveraging AI tools (e.g., ChatGPT, Copilot, Claude) for workflow optimization, analysis, or automation.
• Strong understanding of system integration concepts (APIs, data flow, platform connectivity preferred).
• Experience with Quality Management Systems (QMS) and regulated environments.
• Strong data analysis skills and experience with visualization tools (e.g., Tableau, Power BI).
• Proven ability to identify automation opportunities and independently drive solutions from concept through implementation.
• Strong technical writing skills with the ability to document workflows, logic, and system requirements clearly.
• Ability to work cross‑functionally and translate between technical and non‑technical stakeholders.
• Strong problem‑solving skills with a focus on scalable, sustainable solutions.

• Experience with Salesforce ecosystem (Flows, integrations, or admin-level capabilities).
• Experience in pharmaceuticals, healthcare, or regulated environments.
• Knowledge of DSCSA and system-based compliance…