Quality Manager - IVD Reagent Components

Job Description

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our team now at Siemens Healthineers as Senior Quality Manager - IVD Reagent Components.

The Sr. Quality Manager will lead the quality group at the Elkhart site and lead maintenance and support of the Quality Management System activities for manufacture of in-vitro diagnostic reagent components at the Siemens Healthineers Elkhart Site. This position also serves as the Site Management Representative.

This position interacts with multiple functions across sites including Quality, Manufacturing, Assay Development, Technical Operations, Regulatory, and OEMs.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Quality Manager, you will be responsible for: 

  • Managing organization unit(s) assigned, and leading and/or coordinating dedicated supervisors and professionals.
  • Collaborating with the QM-network and business accountable units (e.g. R&D, Purchase, HPS etc.)  to achieve quality business goals.

  • Ensuring implementation and improvement of the quality part of the Integrated Management System (including process management) for the respective organization according to the overall quality strategy and respective local regulations.

  • Executing the audit program (including certification where applicable) and assessments.

  • Implementing the global quality programs within the local organization and monitors the effectiveness of these programs.

  • Driving continuous improvement with management and lessons learned across assigned organizations.

  • Ensuring that product safety activities are in line with internal and external regulations.

  • Contributing to analyze customer quality requirements and satisfaction appropriately in order to meet customer expectations.

  • Ensuring that quality specific external communication towards customers and to external authorities.

  • Ensuring professional non-conformance (NC) management and reporting using established systems and tools.

  • Leading CAPA, Change and Material review boards.

  • Ensuring and controlling implementation of quality methods and risk management in processes, projects and products (8D, RCA, Q-Gates, FMEA)

  • Ensuring and improving the relevant quality reporting including Management Review.

  • Executing with HR the competence management and training system for quality related competences.

  • Implementing and adapting the communication to ensure understanding and awareness of specific quality topics.

  • As site Management Representative, leading external and internal audits.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers.  Preferred Knowledge/Skills, Education, Experience includes:

  • ASQ Certification.
  • IVD Experience.

  • SAP Quality Management experience.

  • Lead Auditor certification.

Required skills to have for the success of this role

  • BS in Life Science – Biochemistry, Biology, or Chemistry disciplines preferred.
  • Technical expertise in the applicability of 21 CFR 820 regulations and ISO 13485:2016 standard requirements.

  • Previous management experience.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.



Job ID: 184396

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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