Philips Complaint Handling Business Process Expert 

Germany, Hesse 

160598847

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 work with a global cross-functional team as a liaison and subject matter expert.

In your role you will:

• Accountable for representing the Business in complaint handling deliverables by acting as a liaison between the business, market, and Shared Service.
• Liaison with product experts within the business (R&D, Clinical, Manufacturing, sustaining) to address product specific issues related to customer complaints, in order to ensure robust complaint investigations are conducted.
• Work together with R&D and the Failure Analysis lab; ensuring accuracy and timeliness of investigations of failed parts.
• Develop and implement training materials and train associates on all procedures, policies, and guidelines.
• Support Quality management System activities related to complain handling and complaint data for CAPA, Corrections and Removals (C&R), training management review and internal and external audits.
• Analyze complaint data gathers additional data as needed, and partners cross functionally to provide feedback to the BIU supporting complaint evaluation and/or to the PMS management on potential process and quality improvements.
• Lead, develop and implement corrective and preventive actions to address complaint handling and medical device reporting issues, as required.
• Escalate to the Complaint Handling Business Lead when necessary to determine the action to drive timely and effective resolution of the complaint.

You're the right fit if you have:

• Bachelor’s or higher degree preferably in Engineering or Science.
• 5+ years of related experience 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.
• Strong product improvement drive and passion for Customer satisfaction, Patient Safety and Quality applied to daily work.
• Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways.
• Strong written and oral communications skills.
• High reliability and quality focus, 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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