Principal Product Complaint Analyst

This includes improving complaint handling and regulatory reporting processes, leveraging data analytics to identify risks and opportunities, and supporting continuous improvement initiatives across multiple divisions. In this highly visible role, you will collaborate with cross-functional and multisite stakeholders, communicate project progress and strategic recommendations to senior leadership, and influence decisions in complex environments.

Responsibilities

• Understand and ensure compliance with U.S. and outside-U.S. regulatory requirements for medical device complaint handling and regulatory reporting.
• Lead large, high-impact projects within the Global Quality Community to improve post-market quality across multiple divisions.
• Coordinate concurrent project activities and facilitate collaboration among multisite, cross-functional stakeholders to achieve project deliverables and timelines.
• Communicate project deliverables, milestones and timelines clearly and effectively to senior leadership.
• Influence change and align stakeholders to drive informed decision-making in situations with limited information.
• Provide audit support during front-room and back-room activities.
• Serve as a positive cultural leader by modeling high-quality work, effective communication, resilience and solution-oriented thinking.
• Utilize data and analytics to identify risks, opportunities and business priorities.
• Support the development and implementation of new standard operating procedures and work instructions to improve and standardize complaint handling and regulatory reporting processes.
• Apply systems-thinking to evaluate complex quality systems, identify process improvements, assess risk and implement sustainable solutions.
• Identify, escalate and help resolve risks while respectfully challenging existing processes and providing recommendations for improvement.
• Work independently across functions and organizational boundaries to achieve business objectives.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.

Required Qualifications

• Bachelor's degree, preferably in a scientific, engineering or technical discipline.
• Minimum of 8 years' experience in the medical device industry.
• Demonstrated ability to adapt to changing priorities while contributing effectively in a dynamic environment.
• Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint and Visio.
• Working knowledge and practical application of FDA, ISO and MDR regulations within the medical device industry.
• Demonstrated project management experience.
• Ability to travel up to 5% of the time.

Preferred Qualifications

• Experience with nonconformance and corrective and preventive action (CAPA) processes.
• Strong research, communication and presentation skills.
• Excellent written and verbal communication, technical writing and editing skills.
• Demonstrated ability to work independently with minimal direction or supervision.
• Experience with SAS, Snowflake or similar querying and analytics software.