Quality Engineer, Medical Diagnostics & Compliance

Ametek, Inc.; Depew (IA); Presencial; USD 85.000 - 125.000; Jornada completa

Descripción de la vacante

Ametek, Inc. is seeking a Quality Engineer to ensure the quality, reliability, and regulatory compliance of innovative medical diagnostic instruments.

You will partner with R&D, Engineering, Operations, and Supply Chain to establish quality standards and support regulatory requirements. This role offers the opportunity to influence product quality, contribute to operational excellence, and support the development of healthcare solutions through advanced metrology, SPC/DOE, and data-driven

Formación

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 3-5 years of quality engineering experience within the 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 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.
• Strong analytical and problem-solving skills with sound decision-making abilities.
• Effective written, verbal, and presentation communication skills.
• Proven ability to collaborate effectively across multiple functions and organizational levels.
• Certified Six Sigma Green Belt.
• Demonstrated ability and willingness to use AI tools to improve productivity, decision-making, work quality, and reduce costs while critically evaluating AI-generated outputs.

Responsabilidades

• 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 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 teams 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.
• Use AI tools appropriately to improve productivity, decision-making, work quality, and cost efficiency, while critically evaluating AI-generated outputs.

Conocimientos

CAPA leadership

Root cause analysis

Risk management

Validation leadership

Statistical analysis

Six Sigma Green Belt

FDA/regulatory knowledge

Cross-functional collaboration

AI tool usage

Educación

Bachelor’s degree in Engineering or Life Sciences

Descripción del empleo

Ametek, Inc. is seeking a Quality Engineer to ensure the quality, reliability, and regulatory compliance of innovative medical diagnostic instruments.

You will partner with R&D, Engineering, Operations, and Supply Chain to establish quality standards and support regulatory requirements. This role offers the opportunity to influence product quality, contribute to operational excellence, and support the development of healthcare solutions through advanced metrology, SPC/DOE, and data-driven