Quality Engineer II

Job Responsibilities:

• Support and maintain quality management systems and critical process control programs.
• Manage change controls, including quality impact assessments, implementation planning, and completion of change records.
• Lead and participate in quality investigations, including root-cause analysis, event reconstruction, corrective actions, and preventive actions.
• Develop, review, edit, and approve SOPs, validation protocols/reports, quality plans, specifications, investigations, and other QMS documents.
• Develop and review validation documentation for products, processes, and equipment.
• Support calibration, preventive maintenance, environmental monitoring, and other critical control programs.
• Support new/improved product and process launches and technology transfer from development to commercialization.
• Perform statistical analysis, trending, sampling-plan development, and Statistical Process Control (SPC) activities.
• Prepare monthly/quarterly quality trending and analysis reports.
• Support Quality Management Review activities.
• Participate in FDA inspections, ISO certification/surveillance audits, and customer audits.
• Work cross-functionally with Engineering, Operations, Quality, and other teams to resolve problems and maintain compliance.
• Work independently with minimal supervision while managing multiple quality activities

Skills:

• GMP / GxP
• Controlled / regulated manufacturing environments
• Quality Engineering / Quality Assurance
• Change Management / Change Control
• Quality Investigations
• Root Cause Analysis
• CAPA
• Validation
• Data Integrity
• 21 CFR Part 11
• FDA QMSR / 21 CFR Part 820
• ISO 13485
• EU MDR / Regulation 2017/745
• Calibration & Preventive Maintenance
• Environmental Monitoring
• Quality Systems / QMS
• SOP / Protocol / Report Authoring
• Statistical Analysis
• Statistical Sampling Plans
• Statistical Process Control / SPC
• Data Trending
• Quality Impact Assessments
• Audit Support
• Electronic Quality Management Systems / eQMS
• ERP Systems
• Microsoft Office/Suite
• Data-driven decision making
• Cross-functional problem solving
• Project Management
• Coding/Scripting or complex data-management validation — plus

Education/Experience:

• Bachelor's degree in Science or related field required; Master's preferred.
• Relevant experience may be considered in lieu of some education requirements.
• Demonstrated experience working in GMP cleanrooms or controlled/regulated environments — MUST HAVE.
• Experience in change management, data integrity, systems development/validation, or data integration/trending.
• Understanding of statistically based sampling plans and analytical tools.
• Demonstrated data-driven decision-making ability.
• Strong organizational, communication, and project-management skills.
• Ability to work independently with minimal supervision.
• Knowledge of applicable quality/regulatory standards and international regulations.
• ASQ, RAPS, or similar quality/regulatory certification preferred.
• Experience with Data Integrity is a major differentiator/strong plus.
• Medical device/manufacturing quality experience would be highly relevant given the ISO 13485, QMSR, and MDR requirements.