Head of Post Market Surveillance
Philips
- Pittsburgh, PA
- $137,000-236,000 per year
- Permanent
- Full-time
- The Head of Post Market Surveillance will lead complaint handling as Process Owner, Functional leadership as head of the Supervisory Organization, with budgetary responsibility.
- Lead activities related to defining and launching initiatives associated with Field Corrective Actions and Field Safety Notices.
- Act as the key point of contact for Competent Authorities and Notified Bodies for issues related to the performance of the product in the field including Field Actions.
- Collect and report on the performance of the SRC products in the field.
- Establish and manage KPIs related to:
- Timely completion of complaint investigations and adverse events reporting.
- Efficiency and effectiveness of the PMS components of the quality system
- Provide post-market performance data to the Product Teams for the purpose of design improvements.
- Ensure alignment between the SRC post-market processes with Philips Quality Management System.
- Participate as a Business Process Expert with the development and implementation of the post-market surveillance components in the Philips QMS.
- Participate with the rest of SRC Quality Leadership Team in providing an effective and efficient Sleep & Respiratory Care QMS.
- This Hybrid role may require travel up to 10%.
- You’ve acquired a minimum of 10 years’ experience working in FDA regulated medical device quality environments, with a focus in Post Market Surveillance and Complaints Management.
- You have a minimum of 5 years’ proven experience in Strategic and Functional Leadership.
- You’re experienced in process improvement, six sigma, lean manufacturing or equivalent.
- You have extensive experience leading FDA and regulatory body site inspections.
- You have the proven ability to balance regulatory compliance with business objectives using a risk-based approach.
- You’re effective at making plans, decisions, and working in a dynamic environment where priorities can change, and interruptions occur on a regular basis
- You have a minimum of a Bachelor’s Degree in Engineering, Quality, Regulatory or comparable disciplines.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this
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