Quality Engineer, Medical Diagnostics

AMETEK Inc.; Village of Depew (NY); On-site; USD 80,000 - 95,000; Full time

Job summary

AMETEK, Inc. seeks a Quality Engineer to ensure the quality, reliability, and regulatory compliance of innovative medical diagnostic instruments.

This role partners with R&D, Engineering, Operations, and Supply Chain to establish quality standards, support regulatory compliance, and improve manufacturing and business processes. The successful candidate will have a bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline and 3–5 years of quality engineering

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 3-5 years of quality engineering experience within a regulated manufacturing environment.
• Experience leading CAPA investigations, nonconformance management, root cause analysis, and corrective action implementation.
• Experience supporting risk management activities throughout the product lifecycle.
• Experience leading process, equipment, software, test method, and manufacturing validation activities.
• Experience supporting internal audits, supplier audits, customer audits, regulatory inspections, and quality system compliance activities.
• Knowledge of calibration systems, metrology equipment, measurement techniques, and quality engineering tools.
• Experience applying statistical analysis and quality improvement methodologies, including SPC, MSA, DOE, and process capability analysis.
• Certified Six Sigma Green Belt.
• Demonstrated ability and willingness to use AI tools to improve productivity, decision-making, work quality, and to reduce costs.

Responsibilities

• Lead quality engineering activities supporting the development, manufacture, and continuous improvement of medical diagnostic instruments.
• Develop, implement, and maintain quality procedures, work instructions, forms, and quality system documentation.
• Manage updates to quality system documentation, including design control records, device master records, validation records, manufacturing documentation, and supplier quality files.
• Support document change activities to ensure compliance with regulatory requirements and product specifications.
• Partner with R&D, Engineering, Operations, and Supply Chain to establish and maintain quality standards for new and existing products.
• Lead validation activities for new or modified manufacturing processes, equipment, software, test methods, and inspection systems.
• Support design control activities, risk management initiatives, design verification, design validation, and product transfer activities.
• Review manufacturing records, quality documentation, labeling, and product release documentation to ensure compliance with applicable requirements.
• Lead investigations of customer complaints, nonconformances, and CAPA activities to identify root causes and implement sustainable solutions.
• Support supplier qualification, supplier performance monitoring, supplier audits, and resolution of supplier quality issues.
• Participate in customer, supplier, regulatory, and internal quality system audits and support regulatory inspections.
• Develop, analyze, and communicate quality metrics, trends, and improvement opportunities to leadership.
• Maintain and improve calibration programs, measurement systems, and inspection processes.
• Program and utilize advanced metrology equipment to support inspection, measurement system analysis, and process improvement initiatives.
• Apply statistical quality engineering tools, including SPC, MSA, DOE, and data-driven problem-solving methodologies.
• Mentor and support the development of team members while providing quality engineering guidance across functional teams.
• Identify and implement continuous improvement initiatives using Lean, Six Sigma, and operational excellence methodologies.
• Demonstrated ability to use AI tools to improve productivity, decision-making, work quality, and to reduce costs.

Skills

CAPA investigations

Risk management

Validation activities

Audits

SPC/MSA/DOE

Statistical analysis

AI tools usage

Six Sigma Green Belt

Collaboration across functions

Analytical and problem-solving

Communication skills

Education

Bachelor’s degree in Engineering, Quality, Life Sciences

Tools

ISO 13485

FDA QSR knowledge

Job description

AMETEK, Inc. seeks a Quality Engineer to ensure the quality, reliability, and regulatory compliance of innovative medical diagnostic instruments.

This role partners with R&D, Engineering, Operations, and Supply Chain to establish quality standards, support regulatory compliance, and improve manufacturing and business processes. The successful candidate will have a bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline and 3–5 years of quality engineering