Supplier Quality Engineer
Siemens
- Mishawaka, IN
- Permanent
- Full-time
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 .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
- 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
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
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