Senior Quality Engineer

Carestream; City of Rochester (NY); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

The NDT Senior Quality Engineer will own the Quality Management System for NDT manufacturing, developing and improving quality processes, inspection methods, and corrective actions to meet customer and regulatory requirements.

You will lead cross‑functional teams with Manufacturing, Supply Chain, and Engineering to drive product quality and operational excellence, applying data analysis and structured problem‑solving to reduce defects.

Qualifications

• Bachelor’s degree in STEM field.
• Minimum 7 years of quality engineering experience in a regulated manufacturing environment.
• Working knowledge of ISO 9001 and quality systems.
• Experience with root-cause analysis and CAPA activities.

Responsabilités

• Serves as the Quality Subject Matter Expert for NDT manufacturing operations.
• Leads quality activities for electromechanical assembly, testing, inspection, packaging, and service.
• Initiate and lead investigations of defects, nonconforming material, supplier issues, and customer complaints using structured root‑cause analysis.
• Monitor supplier quality, product performance, and CAPA data with statistical methods to improve process capability.
• Develop and maintain control plans, inspection plans, sampling methods, and quality documentation.
• Plan and execute qualification, manufacturing validation, measurement‑system, and change‑control activities.
• Conduct internal, external, customer and regulatory audits to ensure conformance.

Connaissances

Analytical thinking

Project management

Written communication

Verbal communication

Formation

Bachelor's degree in STEM

Description du poste

The NDT Senior Quality Engineer supports our NDT manufacturing operations . This position owns the Quality Management System and will develop, implement, and improve quality systems, process controls, inspection methods, and corrective actions according to all applicable regulatory requirements. The NDT Senior Quality Engineer position is also responsible for ensuring incoming material supply, products and processes consistently meet customer, regulatory, safety, and quality requirements. They serve as the quality leader within a cross‑functional team, utilizing data analysis and structured problem‑solving techniques to identify risks, eliminate defects, and improve process capability. This position ensures compliance with the organization’s Quality Management System and applicable requirements (i.e. ISO 9001, and customer‑specific requirements). The position partners closely with Manufacturing, Supply Chain, and Engineering, and to drive product quality and operational excellence.

Position Responsibilities:

• Serves as the Quality Subject Matter Expert for the NDT manufacturing operations.
• Combines quality ownership and leadership with hands‑on quality engineering support and lead quality activities for electromechanical assembly, testing, inspection, packaging, and service operations to ensure products and processes meet approved specifications and quality requirement.
• Initiate, conduct, lead and/or facilitate, investigations of manufacturing defects, nonconforming material, supplier issues, service failures, and customer complaints using structured root‑cause analysis, risk assessment, and corrective and preventive action methods.
• Monitor and analyze supplier quality, product performance, and CAPA data to ensure reduced service needs due to out‑of-box defects using statistical methods and key metrics to identify trends, reduce defects, and improve process capability and product quality.
• Develop and maintain control plans, inspection plans, sampling methods, acceptance criteria, quality procedures, work instructions, investigation reports, and other controlled quality documentation.
• Plan, review, and execute qualification, manufacturing validation, measurement‑system, and change‑control activities for manufacturing processes, equipment, software, test methods, inspection systems, products, and materials.
• Conduct internal, external, customer and regulatory audits to assess supplier qualification and improvement, quality‑system compliance, and employee training, etc. to ensure continued conformance with applicable regulatory, customer, and company requirements.

Required Skills & Education:

• Bachelor’s degree in any STEM field (including mechanical, electrical, industrial, manufacturing, biomedical, or a related engineering discipline).
• Minimum 7 years of quality engineering experience (in a regulated manufacturing environment preferred).
• Working knowledge of ISO 9001 and experience applying quality‑system, documentation, risk‑management, and regulatory requirements within a manufacturing environment.
• Demonstrated experience investigating product and process nonconformities, leading structured root‑cause analysis, and implementing sustainable corrective and preventive actions.
• Experience analyzing manufacturing data and developing process controls, inspection plans, acceptance criteria, validation documentation, or other manufacturing quality records.
• Strong analytical, project‑management, written, and verbal communication skills.

Desired Skills:

• Experience with supplier qualification, supplier audits, supplier corrective actions, statistical‑analysis software, enterprise resource planning systems, or electronic quality‑management systems.
• Experience in diagnostic‑equipment, radiographic‑imaging, or another regulated manufacturing environment.
• Experience supporting electromechanical assembly, system‑level testing, troubleshooting, returned‑product analysis, installation, or service operations.
• Experience with process validation, equipment qualification, test‑method validation, measurement‑system analysis, statistical process control, process capability analysis, or design of experiments.
• American Society for Quality Certified Quality Engineer, Lean Six Sigma Green Belt or Black Belt, or ISO 13485 or ISO 9001 audit certification or training is preferred

Traditional Office Environment: This position is primarily an office setting with standard temperature and humidity controls, moderate to light noise, fluorescent lighting, primarily sitting with standing desks available, extensive computer and keyboard use, etc. This includes home office settings for remote eligible positions.