Quality Engineer

Ametek, Inc.•Village of Depew, NY

13d

About The Position

As a Quality Engineer, you will help ensure the quality, reliability, and regulatory compliance of medical diagnostic instruments. You will collaborate with Research & Development, Engineering, Operations, and Supply Chain to establish quality standards, support regulatory compliance, improve manufacturing and business processes, and help deliver products that meet customer and regulatory expectations. The role offers the opportunity to influence product quality, contribute to operational excellence, and support the development of healthcare solutions.

Requirements

Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline.
3–5 years of quality engineering experience in medical device, diagnostics, life sciences, or another highly regulated manufacturing environment.
Working knowledge of regulated manufacturing environments, FDA Quality System Regulations, and applicable international quality standards.
Experience leading CAPA, complaint investigations, nonconformance management, root cause analysis, and corrective action implementation.
Experience supporting risk management throughout the product lifecycle.
Experience leading process, equipment, software, test method, and manufacturing validation activities.
Experience supporting internal, supplier, and 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.
Strong analytical and problem-solving skills and sound decision-making abilities.
Effective written, verbal, and presentation communication skills.
Ability to collaborate effectively across multiple functions and organizational levels.
Certified Six Sigma Green Belt.
Ability and willingness to use AI tools to improve productivity, decision-making, work quality, and reduce costs while critically evaluating AI-generated outputs.

Nice To Haves

Experience supporting medical devices, in vitro diagnostics, or diagnostic instrumentation.
ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Six Sigma Black Belt (CSSBB), or similar professional certification.
Working knowledge of ISO 13485.
Certified Lead Auditor or Internal Auditor experience supporting ISO 13485 quality management systems.
Experience supporting supplier quality management programs and supplier development initiatives.
Experience with advanced metrology equipment, statistical software, and measurement system analysis.
Knowledge of design controls, product development processes, design transfer, and product lifecycle management.
Experience leading continuous improvement initiatives using Lean, Six Sigma, or operational excellence methodologies.
Experience supporting FDA inspections, notified body audits, or other external regulatory assessments.

Responsibilities

Lead quality engineering activities supporting 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 design control records, device master records, validation records, manufacturing documentation, and supplier quality files.
Support document changes to ensure compliance with regulatory requirements and product specifications.
Partner with Research & Development, Engineering, Operations, and Supply Chain to establish and maintain quality standards for new and existing products.
Lead validation of new or modified manufacturing processes, equipment, software, test methods, and inspection systems.
Support design controls, risk management, design verification, design validation, and product transfer.
Review manufacturing records, quality documentation, labeling, and product release documentation for compliance.
Lead customer complaint, nonconformance, and CAPA investigations to identify root causes and implement sustainable solutions.
Support supplier qualification, performance monitoring, 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 use advanced metrology equipment for inspection, measurement system analysis, and process improvement.
Apply statistical quality engineering tools, including SPC, MSA, DOE, and data-driven problem-solving methodologies.
Mentor and support team members and provide quality engineering guidance across functional teams.
Identify and implement continuous improvement initiatives using Lean, Six Sigma, and operational excellence methodologies.
Use AI tools appropriately to improve productivity, decision-making, work quality, and cost efficiency, while critically evaluating AI-generated outputs.