Job Information
Philips Senior Technical Complaint Investigation Specialist in Best, Netherlands
Senior Technical Complaint Investigation Specialist
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.
Your role:
Focus on developing long term strategy for timely and appropriate action on the technical investigations of High-Risk complaints: ensuring correct identification, preparing complaint technical and part investigation strategy, reviewing complaint investigation, vigilance reporting and supporting further QMS activities such as Product Defects, Supplier Quality, CAPA intake and Corrections and Removals (C&R).
Creates and deploys technical investigation guidelines for malfunctions and new reportable C&Rs. Support creating bi-directional traceability from complaints to CAPA’s.
Identify groups of complaints relating to similar failures and what is needed from R&D to perform a complete technical investigation
Technical investigations for Customer feedback and for Customer letters
Failed Parts return process: Quality review of parts reports
Support usage of AI and/or Large Language Models (LLM’s) and tooling in order to improve complaint investigation
Setting strategy and proposing solutions such as tooling, automation and simplification of complaint technical investigation through the use of AI & LLM’s.
Accountable for representing the Business in complaint handling deliverables by acting as a liaison between the business, market, and Shared Service.
Acts as a Liaison with product experts within the business (R&D, Clinical, Manufacturing, sustaining) to address product specific issues related to customer complaints, to ensure robust complaint investigations are conducted.
Supports Quality management System activities related to complaint handling and complaint data for CAPA, Corrections and Removals (C&R), training management review and internal and external audits.
Analysis complaint data gathers additional data as needed, and partners cross functionally to provide feedback to the BIU supporting complaint evaluation and/or to the Post Market Surveillance management on potential process and quality improvements
Assess critical events and elevate and engage appropriate management when required
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.
Over 7 years of relevant experience as a Senior SME or Lead within the medical device or regulated industry, specializing in either Quality or R&D domain:
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 and/or 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.
How we work together
We believe that we are better together than apart. For this office-based role, this means working in-person at least 3 days per week.
About Philips
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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.