Supplier Quality Engineer
Siemens Healthcare Diagnostics Inc.

Job Info

---

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.

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://www.siemens-healthineers.com/en-us/careers .

Supplier Quality Engineers are primarily responsible for all quality related aspects of raw material entering the site. This includes day to day support of the manufacturing lines, interfacing with suppliers, and non-conformances that may be generated. The role works closely with the manufacturing, engineering, and procurement teams to assure compliance with all appropriate regulations and specifications. Prompt responsiveness is a requirement to avoid downtime.

Duties and Responsibilities:

• Support design transfer of new production coming into the facility, including raw material specification development, supplier audits and supplier monitoring/qualification, and development of incoming inspection processes
• Interact with multiple functions across sites including Engineering, Manufacturing, Technical Operations, and Regulatory Compliance
• Become Subject Matter Experts on all aspects of each raw material
• Lead the material review process to resolve material non-conformances
• Write or revise necessary production-controlled documents as needed
• Participate as a manufacturing Subject Matter Expert on any process change to assure that proper documentation, validations, and/or qualifications are performed
• Responsible for assuring prompt completion of process related quality notifications and tracking/reporting all necessary tasks to assure completion.
• Serve as Quality Notification coordinator
• Participate in root cause investigations.
• Participate in CAPA Review Board as required
• Participate in Validation Review Board as required
• Prepare for FDA inspections and registrar audits
• Able to effectively communicate with internal and external customers

Required Knowledge/Skills, Education, and Experience:

• The successful candidate will possess a B.S. in science/engineering (preferred). Also acceptable with equivalent experience.
• 2-5 years' experience
• Seeking experienced supplier quality auditor with certifications
• Experience in the medical device/pharmaceutical industry with background in supplier quality. Knowledgeable of all industry regulations and requirements
• Process Control Technology experience is helpful
• Statistical knowledge and Design of Experiments experience
• Strong procedure development/technical writing skills
• Strong communications background, both written and verbal

Other characteristics of the successful candidate:

• Very organized, detail-oriented

• Highly self-motivated

• Able to work independently

• Excellent analytical, communication, writing, and problem-solving skills

• Effective and influential in his/her interactions in team-based assignments

• Able to work well with personnel from different departments, and experience levels

• Ability for potential international travel from time to time

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.

"Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce

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 .

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

#LI-EM1

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.

Reasonable Accommodations
If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accomodation for disablity form If you're unable to complete the form, you can reach out to our AskHR team for support at 1-866-743-6367. Please note our AskHR representatives do not have visibility of application or interview status.

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 .

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here .

---