Sr. Quality System Improvement Specialist

Job Responsibilities

• Develop, analyze, and communicate departmental metrics, complaint trends, and actionable insights; lead recurring KPI reviews to drive data integrity, alignment, and cross-functional action plans.
• Drive the development, implementation, and continuous improvement of complaint handling systems, tools, SOPs, and processes to ensure efficiency, standardization, and compliance with corporate policies and regulatory requirements.
• Ensure timely, accurate, and compliant execution of complaint handling activities in accordance with established procedures, FDA regulations, and service level expectations; maintain audit readiness and support internal and external audits.
• Lead and execute strategic and operational projects, serving as a subject matter expert in complaint management, metrics, trending methodologies, and process governance.
• Partner with Field Assurance and cross-functional leadership to monitor and advance quality improvement initiatives, ensuring accountability, follow-through, and sustained results.
• Develop and update training materials for Field Assurance engaging FA SMEs, QEs, and other external partners.
• Conduct training for FA department new and existing employees, and contractors.
• Responsible for coordinating new employee and contractor’s Onboarding training and schedule while working closely with FA managers/supervisors.
• Lead and facilitate Kaizen and PSP activities, applying structured problem-solving tools (e.g., root cause analysis, process mapping) to identify trends, reduce waste, and drive sustainable improvements.
• Perform additional duties and responsibilities as assigned.

Education and Experience

• Bachelor’s degree in Science, Engineering, or related discipline, with a minimum of five (5) years of relevant technical experience.
• Minimum of four (4) years of experience in an FDA-regulated industry, including hands-on experience in complaint handling and investigation processes.

Knowledge and Skills

• Strong understanding of Corporate and Site Quality Systems, with the ability to implement systemic improvements that enhance processes, support Kaizen initiatives, and drive business efficiency.
• Proven leadership and influencing skills, including the ability to lead Kaizen events, facilitate PSP activities, and drive cross-functional alignment without direct authority.
• Hands-on experience in data analysis within the medical device, pharmaceutical, or biotech industry, including proficiency with tools such as Excel, Minitab, Power BI, and complaint handling systems (e.g., TrackWise).
• Knowledge of Medical Device complaint handling and regulatory reporting requirements.
• Strong analytical and structured problem-solving capabilities, including root cause analysis, process mapping, PSP methodologies, and continuous improvement tools (e.g., Kaizen, Lean principles).
• Excellent interpersonal, communication, and facilitation skills, with the ability to lead improvement workshops, write reports, interpret technical and regulatory information, and effectively present insights to diverse audiences.
• Strong critical thinking skills, including active listening, questioning, assessment, and attention to detail, with a focus on accuracy, consistency, and efficiency.
• Self-motivated and adaptable, with the ability to manage multiple priorities in a fast-paced, matrixed environment.
• Proficient in Microsoft Office applications (Excel, Word, PowerPoint, Visio) and general computer use.
• Ability to interpret business, technical, and regulatory documents and apply mathematical concepts such as ratios, percentages, and data visualization.

Physical Demands

• Sit and talk or hear.
• Frequent hand movement.
• Occasional lifting and moving up to ten pounds.
• Exposure to laboratory environment, which may require handling of all types of chemicals including those that present health, flammability, and reactivity hazards.

Work Environment

• Normal office environment.
• Quiet to moderate noise level.
• Exposure to laboratory environment.