Qualifications:

• High School Diploma or equivalent is required.
• BS degree in engineer or business is preferred.
• Three to five years of experience and/or training, or equivalent combination of education and experience.
• Demonstrated experience in problem solving.
• Demonstrated statistical analysis skills.
• GD&T experience.
• Experience in working with teams to achieve results.
• Understand ISO-13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes.

Requirements:

• Support engineering change process.
• Interface with customer to ensure compliance to customer request and requirements.
• Manage product inspection and testing activities.
• Update production documents including control plan, PFMEA, visual inspection
• Generate quality plans for new product launches
• Maintain the Quality Management System (QMS).
• Approve product for shipment.

Requirements for Medical Product Focus

• Understand ISO-13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes.
• Understand 21 CFR Part 820 Quality System Regulation – Good Manufacturing Practice for the Medical Devices.
• Understand cleanroom gowning practices and cleanliness requirements for manufacturing within a cleanroom.