Product Field Action (PFA) Lead, (Hybrid)

What You Will Do

• Establish and maintain standardized process and procedures 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.

Pay

US15: $102,700 - $171,100 USD Annual
Health benefits include: 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 include: 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.