Quality Engineer – Regulated Manufacturing & Process Control

Carestream; City of Rochester (NY); On-site; USD 80,000 - 120,000; Full time

Job summary

Carestream Health in Rochester, NY seeks a Manufacturing Quality Engineer to support manufacturing operations. You will develop, implement, and improve quality systems, process controls, inspection methods, and CAPA, ensuring products meet customer, regulatory, safety, and quality requirements.

You will collaborate across Manufacturing, Operations, Supply Chain, Engineering, and Regulatory to drive product quality and operational excellence.

Qualifications

• Bachelor’s degree in a related engineering discipline.
• 4+ years of quality engineering experience in a regulated manufacturing environment.
• Working knowledge of ISO 13485 and applying quality-system requirements.
• Experience leading root-cause analysis and CAPA implementations.
• Experience analyzing manufacturing data and developing process controls and quality records.

Responsibilities

• Provide hands-on quality engineering support for electromechanical assembly, testing, inspection, packaging, and service operations to ensure products and processes meet approved specifications and quality requirements.
• Monitor and analyze product, process, supplier, and service quality performance using statistical methods and key metrics to identify trends, reduce defects, and improve process capability and operational performance.
• Lead 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.
• 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, validation, measurement‑system, and change‑control activities for manufacturing processes, equipment, software, test methods, inspection systems, products, and materials.
• Support supplier qualification and improvement, internal and external audits, quality‑system compliance, employee training, and cross‑functional initiatives that ensure continued conformance with applicable regulatory, customer, and company requirements.

Skills

Quality engineering

Root-cause analysis

Data analysis

Project management

Communication

Education

Bachelor’s degree in engineering

Job description

Carestream Health in Rochester, NY seeks a Manufacturing Quality Engineer to support manufacturing operations. You will develop, implement, and improve quality systems, process controls, inspection methods, and CAPA, ensuring products meet customer, regulatory, safety, and quality requirements.

You will collaborate across Manufacturing, Operations, Supply Chain, Engineering, and Regulatory to drive product quality and operational excellence.