Quality Engineer

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 satisfiedManage all aspects of gaging, including calibration activitiesManage non-conforming materials for the shop floor ensuring all requirements are metAid in the processing of Customer ComplaintsMaintain document control for all shop floor quality documentationDevelopment and maintenance of equipment files including assigning asset numbersManage all aspects of CMM operation, including programming, ordering consumables, maintenance, and training operatorsParticipate as a quality representative for PFMEA activitiesPerform routine maintenance of all inspection equipmentConduct routine facility inspections to ensure that Zavation meets all quality and regulatory requirements and report these results to managementFollow and enforce Good Manufacturing Practices (GMP) and other relevant industry regulations and standardsAid in the development of work instructions and proceduresAssist in internal and external audits, as neededComply with all safety procedures and protocolsIdentify and report safety hazards or concernsComplete 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 environmentExperience programming / operating a CMM and vision style measuring systemsExperience supporting manufacturing and quality. Excellent command of ISO and FDA requirements for medical product manufacturingAbility to communicate effectively with direct reportsGood project management and report writing skillsGood communication skills, both oral and writtenAbility to manage multiple projects simultaneouslyExperience with attending ISO certification audits or FDA inspections to answer questions concerning calibration and inspectionAbility 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 controlsFrequently required to talk and hearOccasionally required to stand, walk, and reach with hands and armsMust be able to communicate clearly in both written and verbal formatsMust be able to lift and/or move up to 10 pounds occasionallyRequired to see clearly at close and intermediate distances, and to adjust focus as neededMust be able to work in an office environment with prolonged periods of sitting and working on a computerMinimal travel is expected for this position Powered by JazzHR 7Ma15Bh2OR