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Supplier Quality Engineer-Medical Device Manufacturing (Remote Based)

Job Description

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 a Supplier Quality Engineer  

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

·       Planning, organizing and reporting on all supplier quality-related activities to assure fulfillment of requirements, with specific focus on OEM/ODM Suppliers.

·       Participating as part of a geographically dispersed team of Supplier Quality Assurance Engineers and supports global Supplier Quality visions and strategies. Supports development, communication, deployment and management of overall supplier quality strategies

·       Implementing and maintaining quality improvement programs and auditing systems with our suppliers. These systems should cover the production processes, quality management and record/documentation management at the supplier.

·      Working closely with supplier to demonstrate and maintain stable and capable processes, while working at the supplier's manufacturing site. Translate our performance expectations into measurable methods at the supplier. Understand the supplier's current capabilities and potential new capabilities.

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

·       Conducting periodic Quality management system and process audits at suppliers to verify that process capability requirements are maintained

·       Drive resolution of quality issues back to the supplier. This includes customer complaints and non-conformances. Ensure they are informed of and aligned around quality issue

·       Updating and achieving metrics pertinent to supplier quality.

·       Working with key stakeholders to drive supplier quality agreements, support contract creation and sustain supplier relationship building

·       Act as lead supplier quality representative on new product introduction (NPI) for OEM supplier projects

·       Provides Supplier Quality guidance within the Supplier Quality Assurance group to contribute and support key functions such as: Engineering, Manufacturing, and Procurement groups.

Required skills to have for the success of this role

  • BS/BA in engineering or science discipline.  Advanced degree preferred.
  • 2-3 years of successful experience in supplier quality field or Medical device regulated environment, with focus on Supplier Quality Assurance, required. OEM supplier experience preferred.
  • Advanced knowledge of FDA regulations, EU IVD Directive, new EU IVD Regulations, ISO 13485, ISO 9001 and MDSAP. Experience interfacing directly with regulatory authorities (e.g. FDA) in inspections, preferred.
  • Travel may be up to 30% for this role
  • Strong leadership, listening, verbal and written communication skills
  • Strong structured problem-solving capabilities. Six Sigma knowledge preferred.
  • Must be able to work independently, be self-motivating and act as a change agent

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full vaccination for all new hires by their start date.  (Note: Accommodations may be requested for certain medical or religious reasons).

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

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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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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