Product Field Action (PFA) Lead, (Hybrid)

Stryker is seeking a Product Field Action (PFA) Lead to support our Emergency Care Business . This senior-level quality and post-market leader serves as the Site PFA Lead for the Belfast site and is responsible for overseeing Product Field Action Assessments (PFAA), Nonconformance (NC), and Corrective and Preventive Action (CAPA) processes. Partners across Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations to protect patient safety, maintain product quality, and drive compliant execution of field actions in accordance with FDA, ISO 13485, and ISO 14971 requirements. This position is Hybrid in Redmond, WA or Portage, MI.

What You Will Do

• Establish and maintain standardized process and procedure for executing field action assessments and executions, including but not limited to investigations and identifying solutions.
• Lead and provide strategic direction to Senior Quality Assurance Engineers responsible for Product Field Action Assessments (PFAA), Non-Conformance (NC), and CAPA activities.
• Lead Product Field Action monthly Board review
• Develop strategies and plans for field actions in alignment with organizational goals and objectives.
• Ensure alignment with current regulatory standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and applicable global regulations.
• Identify potential risks associated with field action decisions and implement measures to mitigate them effectively.
• Serve as the escalation point for complex investigations, risk evaluations, and cross-functional decision-making.
• Monitor key performance indicators (KPIs) to evaluate the effectiveness of the field action process and implement improvements as necessary.
• Mentor and coach Senior QA Engineers and broader teams on risk management principles, investigation rigor, and PFA expectations.
• Collaborate with internal stakeholders, such as PFA assessment and execution owners, engineers, and technicians, to ensure seamless coordination and communication regarding field action deliverables.
• Maintain a customer-centric approach by ensuring that field actions are completed promptly and meet or exceed customer expectations.
• Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and safety of field action decisions over time.
• Support internal and external audit activities relating to the PFA process.
• Serves as the voice for the site (Belfast) in divisional and global meetings in the process area.
• Updates key stakeholders and leaders on divisional record deliverables and progress.

What You Need

• Bachelor’s Degree in Science, Engineering, Quality, or a related technical discipline.
• 4+ years of experience in a highly regulated quality, manufacturing, engineering, or medical device environment.
• Experience leading complex investigations and applying root cause analysis methodologies such as 8D and Fault Tree Analysis (FTA).
• Experience utilizing statistical analysis and risk-based methodologies.
• Strong communication, collaboration, and stakeholder management skills.
• Ability to manage multiple priorities and influence cross-functional teams to achieve desired outcomes.

Preferred Qualifications

• Demonstrated Product Field Action (PFA) experience.
• Experience in Post-Market Quality and product field action processes.
• Prior project management experience.
• Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971 requirements.
• Excellent interpersonal, collaborative teamwork, and negotiation skills.
• Proven ability to build trusted relationships across all levels of an organization.
• Strong ability to develop and communicate detailed assessments, execution plans, and potential challenges.
• Experience utilizing quality and project management systems such as: TrackWise, Microsoft Office Suite, SharePoint, Visio

United States of America Pay Ranges:

• US15 : $102,700 - $171,100 USD Annual

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