PMS Process Engineering Senior Manager

Job Title

PMS Process Engineering Senior Manager

Job Description

Post Market Surveillance (PMS) Process Engineering Senior Manager

Join the IGT Systems PMS team and play a pivotal role in shaping and advancing Post Market Surveillance (PMS) processes that safeguard patient safety and elevate product quality. 

Your role: 

• Lead and mentor a team of process experts and technical investigators, promoting collaboration and high standards in Post Market Surveillance (PMS) activities.
• Drive the execution and continuous improvement of PMS processes, ensuring efficiency, compliance, and readiness for regulatory audits.
• Oversee accurate, timely complaint handling and related documentation, and implement dashboards and metrics to monitor and address potential issues proactively.
• Support the design, automation, and enhancement of PMS workflows, including the development of data analytics to detect safety or quality signals and facilitate escalation when necessary.
• Manage Corrective and Preventive Actions (CAPAs) and partner with cross-functional teams, such as the Philips Complaint Handling Unit, R&D, and other stakeholders, to ensure thorough investigation and resolution of complaints.

You're the right fit if: 

• You've acquired 5+ years of experience in Quality in Medical Device and/or other regulated industry preferably in Complaint Handling, Process Improvement, Risk Management, Design Quality, Correction and Removal/Recalls or Product Development. Prior people leadership required. Knowledge of IGT-S products in an advantage.

• Your skills include strong understanding of complaint handling frameworks, CAPA processes, and quality management systems. You have a high reliability and quality focus, ability to successfully balance and prioritize multiple ongoing projects/tasks, and a demonstrated ability to work in a changing environment and be a driver of change. Knowledge of relevant regulations/standards (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR) for regulated industries.

• You have a bachelor's degree or higher in biomedical engineering, science, healthcare, or medical profession or equivalent.

• You're an excellent communicator (written and verbal in English), with strong analytical skills, excellent stakeholder management skills, and strong ability to create collaborative work environments.

How we work together 

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. 

This role is office-based.

About Philips 

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. 

• Learn more about our business here. 
• Discover our rich and exciting history here. 
• Learn more about our purpose here. 

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.