Job Details

Pioneering Breakthroughs In Healthcare

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Responsibilities

Responsible for leading the CLS Immunoassay Commercial Product Quality (CPQ) Team responsible for complaint handling, medical device reporting and Field Action activities for Atellica IM, Atellica CI and ADVIA Centaur assays. This role is responsible for developing and executing organizational strategies, processes, goals, and metrics that drive measurable improvements in complaint handling, product quality, and customer satisfaction. This role leads cross-functional initiatives to enhance the customer experience, reduce quality issues, and ensure compliance with regulatory and internal standards.

• Serving as a Subject Matter Expert for post market topics, processes and tools.
• Ensuring compliance with applicable regulations and standards.
• Drive product safety, product quality, and customer satisfaction related decisions, with appropriate authority (both data-based and risk-assessment-based decisions).
• Establish short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction.
• On time reporting of medical device reports.
• Addressing FDA and other NCA concerns with product recalls to achieve the best outcome (regarding recall classification and where applicable, continued product availability).
• Training and development of group members to satisfactorily complete their job activities and career aspirations.
• Ensuring group members have product and regulatory knowledge to perform their jobs compliantly.
• Driving continuous improvement and excellence in results for Key Performance Indicators (KPIs).
• Foster a culture of continuous improvement, accountability, and customer focus.
• Developing and supporting digitalization strategies for CPQ
• IVDR Plans and Reports for associated product lines
• Cross functional collaboration

This position may suit you best if you are familiar with what is below, and would like to develop your career with Healthineers.

• Demonstrated ability to lead and manage people.
• Direct experience in the in-vitro diagnostics industry.
• Strong communication (written, oral, and listening) and problem-solving skills.
• Strong knowledge in complaint handling, investigations, medical device reporting, field action and CAPA processes.
• Proven experience covering post market topics in front room external inspections (e.g., FDA, TUV, etc.).
• Ability to balance heavy workload, customer needs, patient/operator health/safety and regulatory compliance.
• Strong technical knowledge of supported product lines.

Experience:

• Typically, 8+ years of successful experience in related field and successful demonstration of responsibilities as presented above. Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements.
• Experience in Quality Systems, MDRs and Field Action recommended.
• Advanced degree MAY be substituted for experience, where applicable.
• Willing to travel 20%

Education :

• BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.