EDUCATION/CERTIFICATION

• Bachelor’s degree in a technical/relevant field, with at least five (5) years of Quality Engineering experience in an FDA regulated facility; or an appropriate combination of education, certification, and work experience. ASQ Certification preferred.

REQUIRED KNOWLEDGE

• Knowledge and understanding of regulatory requirements associated with the installation and validation of equipment and processes according to FDA 21 CFR Part 820, ISO 13485, ISO 14971, AATB Standards and other applicable state and federal regulations.
• Thorough understanding of key quality engineering tools including: Failure Mode Effect Analysis (FMEA), Installation Qualification (IQ), Operation (OQ), Performance Qualification (PQ), Test Method Validation (TMV), control plans, process verification, process validation, Process Capability Index (Cpk), Statistical Process Control (SPC), Design of Experiments (DOE), Process Performance Index (Ppk), process data analysis, Design, Measure, Analyze, Improve, Control (DMAIC), Lean manufacturing, Acceptable Quality Limit (AQL).
• Strong communication, project management, and problem-solving skills.
• Proficient in Microsoft Office an electronic quality management systems.

PREFERRED KNOWLEDGE

• Experience with electron beam sterilization processes, validation, and maintenance.
• Understanding of ISO11137, ISO11607, ISO11737, ISO22442, and other relevant standards for medical product packaging.

• 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 Fisher (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 or 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