Assay Design Quality Professional

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.

Apply now for the position of Assay Design Professional and you will be responsible to provide direction in the areas of Design Controls to cross functional teams responsible for new product development or design changes. As the Subject Matter Expert (SME), you must be able to lead some improvement projects and training on the elements within Design Controls.

Your role:

• You will provide guidance to application of design controls in accordance with regulatory expectations. You will participate in regulatory inspections.

• You assist in leading deployment of quality engineering tool for the effective development, transfer, and maintenance of products/process throughout the product lifecycle.

• You utilize quality engineering principles and problem-solving skills (risk analysis and problem-solving methodologies, statistical techniques, etc.) to develop and optimize products/processes that are aligned with the overall Quality and Business vision.

• You will provide guidance, recommendations and implementation plans for adherence to regulatory or expectations related to design controls and quality engineering (e.g., Quality System Regulation, EU IVDD, ISO standards, etc.)

• You will assist in ensuring the development of compliant verification and validation plans and reports. Assist in ensuring the compliant development and validation of appropriate test methods for product and process performance.

• You will assist in ensuring active and thorough investigation of quality issues and effective corrective and/or preventative action.

Your expertise:

• BA/BS degree in Life Sciences, Chemistry, Physical Science or Engineering, or higher.

• Have a Lean/Six Sigma methodologies background.

• 3-5 years' experience in quality, assay development or manufacturing in the IVD industry or related field.

• In-depth knowledge of ISO 13485 and FDA Quality System Regulations.

• Excellent communication, technical writing and computer skills (Word, Excel, PowerPoint, Minitab, Visio, Project)

• Certified Quality Engineer (ASQ, CQE, or equivalent preferred.

• Green Belt or Black Belt certification preferred.

Who we are:

We are a team of more than 71,000 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. Check our Careers Site at https://usa.healthcare.siemens.com/careers.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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