Role and Responsibilities

The Quality Engineer will be responsible for supporting manufacturing and quality departments while ensuring compliance with industry and regulatory standards. Key responsibilities include quality technician supervision, inspection equipment upkeep and calibration, maintenance of equipment records, managing non-conforming material for the shop floor, creation and maintenance of shop floor quality documents, managing all aspects of CMM operation while ensuring compliance with regulations, and safety protocols. The ideal candidate should possess relevant experience, a strong attention to detail, and a commitment to maintaining the required records.

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.

        Requirements:

• 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.

        Physical Requirements:
                The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
 

• 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.