Director – Immunoassay Commercial Product Quality

October 15

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Siemens Healthineers

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Healthcare Insurance • Biotechnology • Medical Device

Siemens Healthineers is a leading MedTech company focused on pioneering breakthroughs in healthcare. They offer a comprehensive portfolio that addresses the entire care continuum for serious diseases, including medical imaging, laboratory diagnostics, point-of-care testing, and digital health solutions. With a commitment to innovation, sustainability, and improving patient access to care, Siemens Healthineers collaborates with healthcare professionals and organizations globally to advance medical technology and enhance patient outcomes.

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

💰 $1.5M Grant on 2021-05

📋 Description

• 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. • Developing and executing organizational strategies, processes, goals, and metrics that drive measurable improvements in complaint handling, product quality, and customer satisfaction. • 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. • Driving continuous improvement and excellence in results for Key Performance Indicators (KPIs).

🎯 Requirements

• Typically, 8+ years of successful experience in related field and successful demonstration of responsibilities as presented above. • Demonstrated ability to lead and manage people. • Direct experience in the in-vitro diagnostics industry. • 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.). • Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements. • Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. • Advanced degree MAY be substituted for experience, where applicable. • Willing to travel 20%.

🏖️ Benefits

• medical insurance • dental insurance • vision insurance • 401(k) retirement plan • life insurance • long-term and short-term disability insurance • paid parking/public transportation • paid time off • paid sick and safe time