Head of Post Market Surveillance

3 weeks ago

Pittsburgh, Pennsylvania, United States Philips Full time
Job TitleHead of Post Market SurveillanceJob Description

The Head of Post Market Surveillance will play a critical role in driving Post Market surveillance and Complaint Handling for Philips Sleep & Respiratory Care products.

Your role:

  • 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're the right fit if:

  • 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 position.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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 improve the lives of others.

  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Read more about our employee benefits.

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.

Philips Transparency Details:

The pay range for this position is $137,000 to $236,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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