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.
• Coordinate new employee and contractor onboarding training and schedule while working closely with FA managers/supervisors.
• Lead and facilitate Kaizen and PSP activities, applying structured problem‑solving tools (root cause analysis, process mapping) to identify trends, reduce waste, and drive sustainable improvements.
• Perform additional duties and responsibilities as assigned.

• Bachelor’s degree in Science, Engineering, or a related discipline, with a minimum of five years of relevant technical experience.
• Minimum of four years of experience in an FDA‑regulated industry, including hands‑on experience in complaint handling and investigation processes.
• Demonstrated professional presence, sound judgment, and a high level of work maturity.
• Preferred experience with Kaizen and PSP methodologies.
• Experience with developing and conducting training.

• 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, and proficiency with tools such as Excel, Minitab, Power BI, and complaint‑handling systems (e.g., Track Wise).
• 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.
• 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, 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.
• Proficiency 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.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Regularly required to sit, talk, and hear. Frequently required to use hands to finger, handle, or feel. Occasionally required to stand and reach with hands and arms and lift and/or move up to ten pounds. Must be able to meet with other personnel in other areas of the building. Specific vision abilities required include…