Regulatory Quality Complaint Manager – Medical Devices
Are you looking to be a part of something exceptional? If working for Siemens Healthineers in the Point of Care Business (POC) Area piques your interest, then this opportunity is for you! We are looking for an experienced complaint handling manager to join our enthusiastic and collaborative team.
The selected professional reports to the Sr. Director of Post Market Quality and will oversee the Designated Complaint Handling Unit (DCU). The DCU is responsible for evaluating, investigating, and resolving regulatory complaints regarding POC medical devices. The DCU works closely with a cross-functional team; including R&D, Product Health Teams, Manufacturing, Service, Procurement, and OEM Supplier Management, to ensure compliance to complaint handling requirements within the Point of Care (POC) Business Line.
- Coordinates complaint-related activities across multiple functions and sites within POC.
- Manages a team of complaint handling specialists responsible for evaluating, investigating, and resolving complaints.
- Manages day-to-day activities related to the complaint process and sets priorities appropriately to ensure timely completion of tasks.
- Develops processes to monitor complaint quality and compliance.
- Leads cross-functional meetings resulting from complaint handling activities.
- Defines and monitors Key Performance Indicators (KPIs) and when necessary, drives improvements based on performance trends.
- Supports projects and drives continuous improvement efforts related to the complaint handling process.
- Provides guidance on the interpretation of procedures, and applicable regulations.
- Facilitates ongoing team training and employee development.
- Supports internal and external audits/inspections as required.
- Contributes to product safety and quality, and customer satisfaction related decisions (both data-driven and risk-assessment-based decisions).
- Other projects as assigned
- BS/BA in a related discipline, advanced degree, or equivalent combination of education and experience.
- Strong technical and clinical knowledge or familiarity with POC IVD products.
- Direct experience handling complaints in the in-vitro diagnostic/medical device industry.
- Experience participating in internal/external inspections (e.g., FDA, TUV).
- Strong organizational and time management skills.
- Strong communication skills (e.g., presenting, written, oral, and listening)
- Basic knowledge of key quality processes (e.g., CAPA, complaint investigation, and field action process).
- Ability to lead and influence without authority.
- Ability to analyze and interpret data,and offer appropriate recommendations.
- Basic knowledge of medical device regulations, requirements, and standards (e.g., 21CFR Parts 803, 806 and 820, ISO13485, ISO14971).
- Proficiency using office tools such as Microsoft Office Suite, specifically Excel, and various other computer software applications.
- Clinical or Laboratory background experience desirable.
- Ability and willingness to travel, as needed (<10%)
Job ID: 180168
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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