Senior Quality Engineer

We are seeking an experienced Senior Quality Engineer to support new technology introduction, validation, and quality engineering initiatives for a global medical device organization. This role will serve as the Quality representative on cross-functional project teams, ensuring new products, processes, test methods, and technologies are successfully transitioned into production while meeting regulatory, quality, and timeline requirements.

• Serve as the Quality Engineering lead on cross-functional teams supporting new technology and product introduction into manufacturing.
• Develop, execute, and maintain validation protocols for new products, manufacturing processes, test methods, equipment, and software.
• Lead revalidation activities resulting from engineering changes, deviations, system upgrades, or material changes.
• Apply statistical analysis to validation activities and establish appropriate production inspection methods, controls, and acceptance criteria.
• Perform quality and risk analyses to identify and mitigate potential risks throughout development and implementation.
• Partner with R&D and Engineering to establish and document Critical-to-Quality (CTQ) characteristics and inspection requirements.
• Lead Design for Inspection activities for new technology introductions, leveraging appropriate technologies to improve consistency and reduce human error.
• Ensure project and operational compliance with applicable Quality Management System requirements, including FDA Quality System Regulations and ISO 13485/ISO 9001.
• Provide technical Quality Engineering support for root cause analysis, complaint investigations, deviations, and corrective and preventive actions.
• Support problem-solving initiatives for new and established manufacturing processes to reduce compliance risk, scrap, rework, and process variability.
• Provide Quality Engineering guidance and influence cross-functional stakeholders to drive effective, compliant solutions

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related technical/engineering discipline.
• 3-5+ years of Quality Engineering experience within a regulated industry, preferably medical devices.
• Demonstrated experience supporting the introduction of new products, processes, equipment, or technologies within a medical device manufacturing environment.
• Strong experience with product verification, process validation, and test method validation.
• Working knowledge of medical device regulatory and quality requirements, including FDA requirements and ISO 13485.
• Experience applying statistical methods and risk-management techniques within validation and manufacturing environments.
• Strong root cause analysis, problem-solving, and corrective action experience.
• Ability to manage multiple projects and priorities while working effectively across Engineering, R&D, Manufacturing, and Quality teams.

• Strong communication and influencing skills
• Cross-functional collaboration and teamwork
• Project management and organizational skills
• Methodical, detail-oriented approach
• Strong technical and analytical problem-solving abilities
• Adaptability within a global, culturally diverse organization
• Ability to navigate challenging situations constructively and drive alignment