• You are part of the Quality Team in the Medical Business Unit and will report directly to the Medical Quality Manager
• You interface daily with external customers, OEM partners and surgeons on product experience and complaints, as well with internal stakeholder teams (Sales, Manufacturing, R&D, Services) as part of the complaint handling process
• You are responsible for the overall handling of complaints according to established processes. This means:
o You evaluate, investigate and document customer complaints and feedback in the Medical Unit for all our product lines (patient-specific guides, implants, models and medical device software) and services we provide to our customers (3D printing, segmentation)
o You determine report ability of adverse events and work together with Regulatory Affairs for reporting of such events to the different local Authorities
o You determine the need for field action based on customer feedback using a risk based approach, you are involved in customer communication when field actions are conducted
o You determine continuous improvement and corrective actions in the processes of the Medical Unit to prevent recurrence of customer complaints. Here, you closely work together with all internal teams to follow-up on action plans.
o You will extract important information (trends, high severity complaints) from the complaint files to make it available for management (executive, portfolio, manufacturing, development, quality) to allow decision making
• You are expected to grow in this function, gradually increasing complexity of the products and processes you will be responsible for, allowing you to explore the full Portfolio the Medical Unit has to offer. Additionally, through this function you can grow into taking process ownership of the Complaint Management process and take up other Quality responsibilities within the Medical Unit.