Job Title:  Quality Engineer

The Quality Engineer plays a critical role in ensuring the quality, reliability, and regulatory compliance of innovative medical diagnostic instruments. This position partners closely with Research & Development, Engineering, Operations, and Supply Chain teams to establish quality standards, support regulatory compliance, improve manufacturing and business processes, and deliver products that consistently meet customer and regulatory expectations. The Quality Engineer contributes to operational excellence, advances product quality, and supports the development of innovative healthcare solutions. The successful candidate will hold a bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline and have 3-5 years of quality engineering experience within a regulated manufacturing environment.

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 Research & Development, 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 corrective and preventive action (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 statistical process control (SPC), measurement system analysis (MSA), design of experiments (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 and willingness to use AI tools to improve productivity, decision-making, work quality, and to reduce costs. The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.

Required Qualifications:

• 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 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.
• Effective written, verbal, and presentation communication skills.
• Demonstrated 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 to reduce costs. The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.

Preferred Qualifications:

• 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.