Senior Quality Engineer

KEY DUTIES AND RESPONSIBILITIES

• Lead and support quality engineering activities across product lifecycle phases (design, development, manufacturing, and post-market).
• Review and approve design control documentation, validation protocols, change control requests, and engineering reports.
• Partners with R&D, Manufacturing, Regulatory Affairs, and other departments to ensure quality is integrated into all processes.
• Participate in risk management activities (ISO 14971) including creation and maintenance of risk files.
• Develops and implements methods for sampling, inspection, testing and evaluation of products and processes.
• Leads the development and implementation of statistical methods and design experiments to support processing development, process control, and process improvement
• Supports Products Development and Operations departments to ensure successful transition of products and processes from design to production by applying quality tools and methods
• Identifies, initiates, and prioritizes, process improvement projects to increase efficiency, reduce cost, and improve quality
• Leads process, equipment, and test method validation activities by ensuring the authoring and execution of protocols and reports are completed in a timely manner. Transfer to Operations by supporting the development of applicable SOPs and WIs and training
• Equipment Examples : Autoclave, Lyophilzer, Refrigerators, Freezers, Incubators, Heat Sealers, Biological Safety Cabinets (BSCs), Cleanroom (ISO Class 7), Centrifuge
• Test Method Examples : Peel Strength, Karl Fischer (Residual Moisture), Microbial, Analytical Chemistry, Cell Culture, Endotoxin
• Process Examples : Terminal Sterilization, Pouch Sealing, Blister Packaging, Extraction, Purification
• Participates in the coordination of calibration activities for production equipment, test equipment, analytical equipment, and the facility using an electronic quality management system
• Develop and write specifications, work instructions, part specifications, and internal test methods
• Train others within the organization on quality concepts and tools
• Responsible for qualification of packaging design changes including evaluation of shelf-life, shipping, and distribution
• Support software validation activities including the authoring and / or review and approval of protocols, test cases, and reports
• Support and perform root cause analysis for deviations, investigations, CAPA and support development and implementation of effectiveness checks.
• Perform change control Validation assessments and attend material review boards as required
• Gather, analyze and publish monthly KPIs for quality metrics as directed by Quality Management
• Drive continuous improvement initiatives using Lean, Six Sigma, and other quality tools. Serves as a point of contact and SME for the Quality Engineering team during regulatory and customer inspections
• Participate as a member of StimLabs' Internal Audit Team
• Mentor junior engineers and provide technical guidance.
• Other tasks and project as assigned by Quality Management

EDUCATION / CERTIFICATION

REQUIRED KNOWLEDGE

PREFERRED KNOWLEDGE

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