Role and Responsibilities

• Supervise quality technicians as needed to ensure all quality and regulatory requirements are met and customer needs are satisfied.
• Manage all aspects of gaging, including calibration activities.
• Manage non-conforming materials for the shop floor ensuring all requirements are met.
• Aid in the processing of Customer Complaints.
• Maintain document control for all shop floor quality documentation.
• Development and maintenance of equipment files including assigning asset numbers.
• Manage all aspects of CMM operation, including programming, ordering consumables, maintenance, and training operators.
• Participate as a quality representative for PFMEA activities.
• Perform routine maintenance of all inspection equipment.
• Conduct routine facility inspections to ensure that Zavation meets all quality and regulatory requirements and report these results to management.
• Follow and enforce Good Manufacturing Practices (GMP) and other relevant industry regulations and standards.
• Aid in the development of work instructions and procedures.
• Assist in internal and external audits, as needed.
• Comply with all safety procedures and protocols.
• Identify and report safety hazards or concerns.
• Complete and/or participate in validation activities.

• Bachelor’s degree in a technical discipline or 10 years of experience working in quality control or quality assurance in a manufacturing environment.
• Experience programming / operating a CMM and vision style measuring systems.
• Experience supporting manufacturing and quality.
• Excellent command of ISO and FDA requirements for medical product manufacturing.
• Ability to communicate effectively with direct reports.
• Good project management and report writing skills.
• Good communication skills, both oral and written.
• Ability to manage multiple projects simultaneously.

• Experience with attending ISO certification audits or FDA inspections to answer questions concerning calibration and inspection.
• Ability to work independently and adhere to timelines.

• Regularly required to sit and use hands to handle or feel objects, tools, or controls.
• Frequently required to talk and hear.
• Occasionally required to stand, walk, and reach with hands and arms.
• Must be able to communicate clearly in both written and verbal formats.
• Must be able to lift and/or move up to 10 pounds occasionally.
• Required to see clearly at close and intermediate distances, and to adjust focus as needed.
• Must be able to work in an office environment with prolonged periods of sitting and working on a computer.
• Minimal travel is expected for this position.