Senior Quality Engineer

Job Type: Full-Time / On-Site

Salary:  $135,000 - $145,000 with 6% bonus target

How You’ll Make an Impact

The Senior Quality Engineer serves as a subject matter expert in quality systems, risk management, validation, process controls, and problem-solving methodologies. This role requires a proactive leader who can influence cross-functional teams, mentor junior engineers, and drive sustainable quality improvements throughout the product lifecycle including compliance to ISO 13485, CFR Title 21 Part 820, ISO 14971.

• Lead the development, implementation, and continuous improvement of quality assurance systems, processes, and controls to ensure product quality and regulatory compliance.
• Provide quality engineering leadership for new product introductions (NPI), manufacturing process development, technology transfers, and process optimization activities.
• Develop, review, approve, and execute validation and verification strategies, protocols, and reports including IQ/OQ/PQ, test method validations, and process validations.
• Lead complex investigations involving nonconformances, complaints, deviations, and CAPAs, ensuring robust root cause analysis and implementation of effective corrective actions.
• Drive cross-functional problem-solving initiatives utilizing advanced quality tools including FMEA, Fishbone Diagrams, 5 Whys, Fault Tree Analysis, DOE, SPC, and statistical analysis methodologies.
• Coordinate and facilitate risk management activities in accordance with ISO 14971, including hazard analysis, risk assessments, and mitigation activities.
• Lead development and maintenance of Process FMEAs, Design FMEAs, Control Plans, inspection strategies, and process monitoring programs.
• Analyze process capability and quality metrics to identify trends, improve process performance, and reduce variation.
• Serve as a quality representative on product development and manufacturing improvement projects, ensuring quality requirements are effectively integrated into project execution.
• Mentor and provide technical guidance to Quality Engineers, Quality Technicians, and cross-functional teams.
• Partner with Manufacturing, R&D, Regulatory Affairs, Operations, and Supply Chain teams to implement sustainable quality improvements and ensure operational excellence.
• Drive supplier quality initiatives, including supplier qualification, monitoring, audits, performance improvement plans, and resolution of supplier-related quality issues.
• Lead internal and external audits, regulatory inspections, and customer audits, serving as a quality subject matter expert.
• Assess, interpret, and implement changes to regulatory standards, quality system requirements, and industry best practices through document control and change management processes.
• Lead Management Review support activities, quality metrics analysis, and continuous improvement initiatives.
• Support customer and regulatory requests including supplier surveys, technical quality assessments, EU MDR compliance documentation, and quality agreements.
• Identify opportunities to improve efficiency, reduce cost of quality, enhance compliance, and strengthen overall quality system effectiveness.
• Influence organizational quality culture by promoting best practices, accountability, and continuous improvement principles.
• Perform other duties and responsibilities as assigned.

Required Qualifications that Enable Your Success

• Bachelor’s degree in engineering or related technical discipline required;
• 5+ years of progressive experience in Quality Engineering, Manufacturing Engineering, or Quality Systems within a regulated medical device environment.
• Experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971, EU MD