Principal Quality Engineer - Medical Devices

at  Medical Murray

Position Title: Principal Quality Engineer
Location: Lake Zurich, IL
Establish your Career with Medical Murray!
Compensation: $120,000 - $160,000 per year (based on experience, skills, and education)

ABOUT US:

At Medical Murray, we’re not just about manufacturing; we’re about making a real difference in healthcare! By combining cutting-edge design, development, and manufacturing expertise, we empower healthcare providers to enhance patient care and quality of life. If you’re passionate about innovation and ready to join a dynamic team dedicated to excellence, we want YOU!

POSITION OVERVIEW:

As our Principal Quality Engineer, you’ll be ensuring compliance with our quality systems, assist with production transfer activities, develop LEAN manufacturing, and establish continuous improvement throughout our quality department. Your work within our quality team will not go unnoticed!

• Support the Quality Manager in identifying and filling site needs for quality resources to meet objectives.
• Understand and document cycle times for quality control steps.
• Develop LEAN work methodology within the manufacturing environment, including processes optimization to improve quality, process repeatability, and achieve cost savings.
• Improve reliability of processes to prevent or reduce failures.
• Champion and participate as a team member on Corrective and Preventative Actions and associated investigations to identify and resolve root causes of problems
• Perform continuous improvement activities with the end goal of improving compliance, quality, and profitability.
• Support risk management activities compliant with ISO 14971.
• Mentor the production quality engineering team in support of and adherence to regulatory requirements and company initiatives.
• Provide guidance to manufacturing engineering, transfer engineering, and production to resolve issues in a compliant manner.
• Review components, products, and processes for optimization of inspection method, sampling plan, and documentation.
• Support validation and verification activities
• Develop protocols and reports for validation activities, including process, test method, and software.
• Assist in maintaining, implementing, and updating the Quality Management System.
• Subject matter expert in EO sterilization cycle and testing.
• Participate in internal audits and represent the company during external audits for FDA, Notified Bodies, and customers.