Product Field Action (PFA) Lead, (Hybrid)

About the role

This senior-level quality and post-market leader serves as the Site Product Field Action (PFA) Lead for the Belfast site. You will oversee Product Field Action Assessments (PFAA), Nonconformance (NC), and Corrective and Preventive Action (CAPA) processes, partnering 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.

Responsibilities

• Establish and maintain standardized processes and procedures for executing field action assessments and executions, including 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.
• Serve as the voice for the Belfast site in divisional and global meetings in the process area.
• Update key stakeholders and leaders on divisional record deliverables and progress.

Requirements

• 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.

Pay

Pay range: $102,700 - $171,100 USD annually.

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.