Sr. Quality Engineer

The Senior Quality Engineer is responsible for leading quality engineering activities that support product development, manufacturing, supplier quality, and the Quality Management System (QMS). This role partners closely with Engineering, Manufacturing, Operations, Regulatory Affairs, Supply Chain, and R&D to ensure products are designed, manufactured, and maintained in compliance with FDA regulations, ISO 13485, ISO 14971, and other applicable regulatory requirements. 

Principal Responsibilities 

• Support and continuously improve the Quality Management System (QMS), including the Quality Manual, Standard Operating Procedures (SOPs), work instructions, forms, and quality records. 
• Lead initiatives to improve quality processes while ensuring compliance with FDA, ISO, and company requirements. 
• Support Management Review activities by preparing quality metrics, trend analyses, and recommendations. 
• Serve as the Quality representative on cross-functional product development teams from concept through commercialization. 
• Lead Design Assurance activities in accordance with Design Controls (21 CFR Part 820/ISO 13485), including: design reviews, design verification & validation; design transfer, and Design History File (DHF) documentation. 
• Ensure appropriate application of risk management principles throughout the product lifecycle in accordance with ISO 14971. 
• Review design changes and evaluate quality, regulatory, manufacturing, and risk impacts. 
• Partner with Operations and Manufacturing Engineering to improve manufacturing processes, product quality, and operational efficiency. 
• Lead investigations of production quality issues using structured problem-solving methodologies. 
• Assess impacts of design and process changes on: DFMEA, PFMEA, process controls, control plans, inspection ethods. 
• Develop statistical sampling plans and acceptance criteria. 
• Lead Nonconformance (NCR) investigations and Corrective & Preventive Action (CAPA) activities. 
• Verify effectiveness of corrective actions and ensure timely closure. 
• Identify recurring trends and recommend systemic improvements. 
• Partner with Supply Chain to qualify, monitor, and improve supplier performance. 
• Participate in supplier evaluations, audits, and performance reviews. 
• Review supplier quality metrics and drive corrective actions when performance expectations are not met. 
• Support incoming inspection strategies and supplier quality agreements. 
• Lead or support equipment qualification and process validation activities including: IQ, OQ, PQ. 
• Review and approve validation protocols and reports. 
• Ensure calibration and preventive maintenance activities comply with QMS requirements. 
• Review and approve Engineering Change Orders (ECO/DCO). 
• Ensure product and process changes are appropriately documented, validated, and implemented. 
• Support cross-functional implementation of engineering and manufacturing changes. 
• Lead and participate in: internal audits, supplier audits, FDA Inspections, ISO Certification Audits, and Notified Body Audits. 
• Support responses to audit observations and implementation of corrective actions. 
• Ensure ongoing compliance with applicable domestic and international regulations. 
• Analyze quality metrics and statistical trends to proactively identify opportunities for improvement. 
• Drive Lean Manufacturing and Continuous Improvement initiatives. 
• Utilize statistical tools to improve product quality and manufacturing capability. 
• Develop dashboards and Key Performance Indicators (KPIs) that measure quality system effectiveness. 
• Mentor and provide technical guidance to Quality Engineers, Inspectors, and cross-functional teams. 
• Lead cross-functional quality improvement projects. 
• Influence quality decisions across Engineering, Operations, Regulatory Affairs, Clinical, and Manufacturing. 
• Promote a culture of quality throughout the organization. 
• Support all Company initiatives as identified by management in support of the Quality Management System and regulatory compliance. 

 Education & Experience 

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, Quality Engineering, or related engineering discipline. 
• Minimum 7–10 years of Quality Engineering experience in the medical device industry. 
• Minimum 5 years supporting FDA-regulated medical device manufacturing. 
• Experience supporting both New Product Development and commercial manufacturing. 
• Demonstrated experience leading cross-functional quality initiatives. 
• Medical device startup experience. 
• Experience supporting Class II and/or Class III medical devices. 
• Experience with process validation methodologies. 
• Excellent project management and organizational skills. 
• Strong analytical and critical thinking abilities. 
• Ability to influence without direct authority and lead cross-functional teams. 
• Excellent written, verbal, and presentation skills. 
• Strong interpersonal and collaboration skills.