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Quality Manager

Quality Manager

Siemens HealthineersAurora, CO, US
1 day ago
Job type
  • Full-time
Job description

Quality Control Manager

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.

Key Responsibilities

  • Lead and develop a team of QC professionals, fostering a high-performance and highly collaborative culture, with a focus on quality, customer, safety, and compliance.
  • Oversee timely and accurate testing of raw materials, intermediates, and finished products.
  • Ensure compliance with FDA, ISO 13485, MDSAP, IVDR, and Siemens Healthineers' Quality Management System (QMS).
  • Develop, monitor, and report on key quality metrics (KPIs), and implement corrective actions where necessary for continuous improvement.
  • Ensure area of responsibility is audit-ready and support internal and external audits.
  • Drive cross-functional collaboration with other stakeholders within Manufacturing, R&D, Technical Operations, Engineering, Quality Assurance, and Regulatory.
  • Manage training, documentation, and qualification records to ensure compliance and readiness.
  • Take ownership of employee skill development, performance management, and career growth planning.
  • Support the development and use of digital tools (e.g., Power BI, Microsoft Copilot) for real-time data visualization, KPI tracking, and decision-making.
  • Proactively track and trend testing issues or inefficiencies for continuous improvement.
  • Work cross-functionally with internal stakeholders to ensure right-first-time mindset to achieve first-pass acceptance.
  • Use HPS (Healthineers Performance System) principles to drive continuous improvement and increase operational efficiency.
  • Promote a culture of safety by implementing EHS policies and best practices.
  • Escalate issues and support root cause investigations and CAPA implementation for quality incidents.
  • Proactively drive operational efficiency and cost-effectiveness while maintaining uncompromised quality standards.

Required Qualifications

  • Bachelor's or Master's degree in scientific discipline (e.g., Chemistry, Biology, Medical Technology, Biotechnology).
  • 5+ years of experience in Quality Control or Quality Assurance in the medical technology, diagnostics, or pharmaceutical industry.
  • Prior management experience is required.
  • The successful candidate is a servant leader with a growth mindset, who leads by example and is committed to developing people and processes. They will foster a culture of transparency, collaboration, and accountability, while ensuring quality objectives are met efficiently and consistently.
  • Proven leadership experience managing large and diverse teams, ideally in a regulated (FDA / MDR / ISO) environment.
  • Demonstrated ability to lead with empathy, humility, and high emotional intelligence (EQ).
  • Strong communication and interpersonal skills with a collaborative and facilitative leadership style.
  • Familiarity with FDA regulations, ISO 13485, Risk management (ISO 14971), and applicable standards for medical devices or diagnostics.
  • We are a team of more than 73,000 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.

    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.

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