Sr. Quality Engineer

📋 Description

• Strong contributor to the planning and execution of design controls, risk management, and design
• Participate in risk management process ensuring that risks are properly identified/assessed and
• Ensure design changes are established and implemented according to ISI standards and applicable
• Recommend design processes and methods to meet quality goals (DFX, etc.).
• Support manufacturing processes, including failure analysis and defect/scrap containments.
• Ensure manufacturing activities follow procedures and comply with USDA regulations.

🎯 Requirements

• 21 CFR 820, ISO 13485 and ISO 14971 requirements for making process or design changes.
• Experience in generating/updating FMEAs.
• Design Controls, Change Controls, Product, and Engineering Processes.
• Generating and executing Qualifications, Validation Protocols and Quality Assurance Procedures.
• Root cause analyses, product containment, and rework activities.
• SPC & Six Sigma methodology and tools (DMAIC, 5 Why's, control charts, fishbone diagram).

🎁 Benefits

• Market-competitive compensation packages inclusive of base pay, incentives, benefits, and equity