Philips Senior Complaint Handling Operations Lead 

Germany, Hesse 

597135244

Senior Complaint Handling Operations Lead
Job Description

You will become part of the Complaint Handling team of the Image Guided Therapy Systems Quality organization, which is responsible for ensuring patient safety and quality, customer satisfaction, and regulatory compliance through the complaint-handling process. Your role will be key in ensuring that complaints are investigated with high quality, leading to safe and effective products and satisfied customers. You will help lead and steer a global cross-functional team as a liaison and subject matter expert.

In your role you will:

• Responsible for driving quality and excellence in complaint handling operations as a Complaint Handling Operations Lead.
• Together with business, drive complaint handling strategy and operating model to ensure Customer satisfaction, Patient safety and Quality and audit readiness for IGTS complaint handling.
• Driving Complaint handling improvement projects and programs.
• Own and support management review and internal and external audits.
• Lead, develop and implement corrective and preventive actions to address complaint handling and medical device reporting issues, as required.
• Liaison with product experts within the business (R&D, Clinical, Manufacturing, Suppliers) to address product specific issues related to customer complaints, in order to ensure robust complaint investigations are conducted
• Escalate to the Complaint Handling Business Lead when necessary to determine the action to drive timely and effective resolution of the complaint.
• Develop and implement training materials and train associates on all procedures, policies, and guidelines.

You're the right fit if you have:

• Bachelor’s or higher degree preferably in Engineering or Science.
• 5+ years of related experience as a Senior SME or Lead in a medical device or regulated industry preferably in:
  • Quality functions such as complaint handling, adverse event reporting and related processes.
  • R&D functions with a high involvement and interest in product quality improvements.
  • Experience leading improvement programs.
  • Experience leading teams and projects.
• Strong product improvement drive and passion for Customer satisfaction, Patient Safety and Quality applied to daily work.
• Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways.
• Strong regulatory writing and audit communication skills.
• High engagement, motivation, and flexibility.
• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169

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