Engineering Design lead

Job Title: LEAD I - ENGINEERING DESIGN 
Experience : 10+ years
Remote
Job Summary
We are seeking an experienced Manufacturing Quality & Power BI Automation Specialist with strong expertise in manufacturing quality management processes, Power BI reporting, business process automation, and AI-driven solutions. The ideal candidate will have hands-on experience with CAPA, Deviations, Change Controls, Investigations, and Process Performance Qualification (PPQ) within regulated manufacturing environments.
The candidate will be responsible for leveraging data analytics, automation tools, and emerging AI technologies to improve quality operations, enhance reporting capabilities, streamline workflows, and support regulatory compliance.
Key Responsibilities

• Support manufacturing quality processes, including CAPA, Deviations, Change Controls, Investigations, and PPQ.
• Develop, maintain, and optimize Power BI dashboards and reports to monitor quality metrics, trends, KPIs, and operational performance.
• Analyze manufacturing quality data to identify trends, recurring issues, process gaps, and opportunities for improvement.
• Design and implement automated workflows using Microsoft Power Platform, including Power Automate and Power Apps, or similar automation tools.
• Identify opportunities to automate manual quality processes, reporting activities, and compliance-related workflows.
• Explore and implement AI/Generative AI solutions for quality reporting, data analysis, document processing, and process optimization.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, IT, Data Analytics, and business stakeholders to deliver effective solutions.
• Ensure dashboards, automation workflows, and AI-enabled solutions align with applicable quality standards, data integrity requirements, and regulatory compliance expectations.
• Support continuous improvement initiatives by providing actionable insights and data-driven recommendations.
• Prepare documentation and support testing, validation, and implementation of reporting and automation solutions as required.

Required Skills and Qualifications
Strong domain knowledge of Manufacturing Quality processes in regulated manufacturing environments.
Hands-on experience with:

• Corrective and Preventive Actions (CAPA)
• Deviations Management
• Change Control Management
• Quality Investigations and Root Cause Analysis
• Process Performance Qualification (PPQ)
• Strong experience developing interactive dashboards and reports using Microsoft Power BI.
• Proficiency in data analysis, data modeling, DAX, Power Query, and data visualization.
• Experience automating business and quality processes using Microsoft Power Automate, Power Apps, or similar tools.
• Ability to work with cross-functional teams and translate business requirements into technical solutions.
• Strong analytical, problem-solving, communication, and stakeholder management skills.
• Understanding of data integrity, documentation, and compliance requirements in regulated manufacturing environments.

Preferred Skills

• Experience with Artificial Intelligence (AI) and Generative AI solutions.
• Knowledge of AI applications in quality analytics, reporting automation, document summarization, and process improvement.
• Familiarity with Microsoft Copilot, Azure AI services, or other enterprise AI platforms.
• Experience integrating Power BI and Power Platform solutions with enterprise data sources and quality management systems.
• Exposure to pharmaceutical, biotechnology, medical device, or other regulated manufacturing industries.
• Familiarity with GMP (Good Manufacturing Practice) and relevant quality management standards.

Key Deliverables

• Power BI dashboards and reports for manufacturing quality metrics.
• Automated quality management workflows and reporting processes.
• Data-driven insights for CAPA, Deviations, Change Controls, Investigations, and PPQ.
• AI-enabled solutions to improve reporting efficiency and quality operations.
• Improved process efficiency, data visibility, and compliance support.
• Ideal Candidate: A professional who combines strong Manufacturing Quality domain knowledge with hands-on Power BI and automation expertise, with AI/Generative AI experience as an added advantage.