Philips Complaint Handling Business Process Expert Clinical Informatics 

Germany, Hesse 

607549328

Your role:

• Responsible for ensuring timeliness and high quality of complaint investigations in the End-to-end complaint handling process.

• Together with BU lead, support complaint handling strategy and operating model to ensure Customer satisfaction, Patient safety and Quality and audit readiness for CI complaint handling.

• Oversight the working relationship between the Business Unit and its partners to ensure smooth handling of customer product complaints.

• Accountable for representing the Business in complaint handling deliverables by acting as a liaison between the business, business unit, market, and Shared Services.

• 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.

• 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.

• Develop and implement training materials and train associates on all procedures, policies, and guidelines.

You're the right fit if:

• You have a Bachelor's Degree in Biomedical Engineering, Biological Sciences, or other related technical degree

• You have 7-10 years of experience in medical device industry and 5+ years in Complaint Handling and 3+ years of experience in Vigilance Reporting

• You have experience with Medical Device Regulatory Requirements and standards such as 21 CFR Parts 820, 803, 806 and ISO 13485

• You have strong written and oral communications skills

• You have experience or affinity in leading teams and people

• You have experience with software, which is preferred

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 the lives of others.
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