Reprocessing Sr. Quality Operations Engineer

Intuitive • Dallas, TX

78d

About The Position

This position works independently to execute various quality processes, including quality control, maintenance, calibration, review boards, and record-keeping. It supports compliance with regulations and procedures while achieving process metrics and maintaining high-quality output. The role involves assessing performance, developing tools, and improving processes to meet customer demands and organizational goals. This is a 1 year full time direct hire, temporary position, for a pilot program.

Requirements

• Minimum 5 years experience in quality operations and a bachelor's degree in engineering discipline, or equivalent combination of education and experience
• Knowledge of process improvement principles and quality systems regulations (21 CFR 820 and ISO 13485)
• Proficient in data analytics and spreadsheet software
• Understanding of technical drawing standards, measurement techniques, maintenance, calibration, and best manufacturing practices
• Comfortable with all phases of product development, including assembly, testing, debugging, transfer, and ongoing support, especially in relation to cleaning and sterilization of Instruments and Endoscopes
• Honest, thorough, and self-motivated with excellent problem-solving skills
• Excellent communication, collaboration, and documentation skills
• Flexible and able to adapt to shifting priorities while working independently

Responsibilities

• Inspection and approval of quality processes and records
• Inspection and approval of raw materials
• Release reprocessed instruments
• Create, analyze, and manage resolution of equipment-related events
• Create and approve engineering changes
• Design tools to support maintenance and calibration activities as required
• Create or update operating procedures and work instructions to improve processes
• Support internal and external audits
• Perform maintenance and calibration of systems as required
• Support other quality operations initiatives (e.g., protein verification, biological indicator release, etc.) as directed

What This Job Offers

• Job Type: Full-time
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree