Staff Specialist, Post Market Quality
About The Position
The Staff Specialist, Post Market Quality (PMQ) serves as a global subject matter expert supporting post-market quality activities across the Medication Management Solutions (MMS) portfolio. This role partners closely with the Senior Manager, PMQ, to drive the execution and continuous improvement of global field actions, post-market surveillance, risk management, quality system integration, and regulatory compliance activities. The Staff Specialist provides technical leadership and strategic support for recalls, corrections, removals, advisory notices, complaint trending, CAPA integration, and regulatory reporting. This position collaborates across Quality, Regulatory Affairs, Medical Affairs, Engineering, Operations, and regional teams to ensure timely, compliant, and effective management of post-market quality activities. The ideal candidate possesses strong expertise in medical device quality systems, regulatory requirements, risk management, and post-market surveillance, with the ability to influence decisions and drive alignment across global stakeholders.
Requirements
- Bachelor's degree in Engineering, Quality, Life Sciences, Regulatory Affairs, or related technical field.
- Minimum 5 years of experience in Quality, Regulatory Affairs, Post Market Quality, Product Quality, or related functions within a regulated industry.
- Experience supporting post-market quality activities, quality investigations, risk management, or field actions.
- Strong analytical, problem-solving, and decision-making skills.
- Demonstrated ability to influence cross-functional stakeholders and drive organizational alignment.
Nice To Haves
- Medical device industry experience.
- Knowledge of global field action and post-market surveillance requirements.
- Experience with complaint handling, CAPA, risk management, and quality system processes.
- Experience supporting regulatory inspections and audit readiness activities.
- Advanced data analytics and KPI development experience.
Responsibilities
- Lead and support the execution of global field actions, including recalls, corrections, removals, advisory notices, and other post-market actions.
- Develop and maintain field action documentation, rationale packages, health hazard evaluations, effectiveness strategies, and closure documentation.
- Partner with regional quality and regulatory teams to support consistent field action implementation across North America, EMEA, LATAM, and Greater Asia.
- Monitor field action progress, effectiveness, reconciliations, and closure activities to ensure compliance with internal and external requirements.
- Support preparation of materials for Field Action Committee (FAC) reviews and decision-making.
- Support development of defensible quality and regulatory decisions through clear documentation and risk justification.
- Identify emerging trends and product performance concerns that may require corrective or preventive action.
- Provide technical expertise during investigations involving product quality, safety, reliability, and compliance issues.
- Support regulatory submissions and notifications including FDA 806 reporting and global field action reporting requirements.
- Prepare and review documentation supporting regulatory agency interactions, audits, inspections, and inquiries.
- Ensure post-market quality activities meet applicable regulatory requirements and company procedures.
- Contribute to inspection readiness activities through strong documentation practices and quality system compliance.
- Develop and maintain key performance indicators (KPIs) and dashboards related to post-market quality and field actions.
- Analyze effectiveness trends, risk signals, reconciliation data, closure performance, and recurring quality issues.
- Generate executive-level reports and summaries to support leadership decision-making.
- Identify opportunities to strengthen data visibility and proactive quality management.
- Collaborate with stakeholders across Quality, Regulatory Affairs, Engineering, Operations, Supply Chain, Medical Affairs, and Commercial teams.
- Provide technical leadership through influence and expertise to achieve alignment on quality and compliance strategies.
- Support global consistency in post-market quality processes and execution standards.
- Serve as a trusted advisor and resource for post-market quality and field action-related matters.
- Drive process improvement initiatives that enhance efficiency, compliance, and effectiveness of post-market quality systems.
- Participate in quality transformation efforts, Kaizen activities, and operational excellence programs.
- Recommend process enhancements based on lessons learned, regulatory expectations, and industry best practices.
- Foster a culture of proactive risk identification and continuous improvement.
Benefits
- Total Rewards program
- Competitive package of compensation and benefits programs
- Performance-based culture
- Opportunities to learn, grow and thrive
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What This Job Offers
Job Type
Full-time
Career Level
Senior
