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 4.
Seeking a driven and experienced Supplier Quality Engineer with Medical Device Experience, to maintain the Supplier Management process, as well as identify and implement improvements to this process. This person will also serve as the Supplier Management’s primary point of contact for Production, as well as serve as liaison between internal functions and assigned suppliers.
This is a role well suited to an ambitious professional, looking for the next step in their career as an experienced Supplier Quality Engineer. You will be responsible for:
- Define and implement improvements to the Supplier Management process; Propose improvements to process that interact with the Supplier Management process.
- Coach/Lead less experienced Supplier Quality Engineers.
- Lead initiatives to improve quality received from assigned suppliers; as needed, conduct supplier visits to aid in the resolution of nonconformances.
- Support the qualification of parts and/or introduction of new suppliers.
- Manage supplier’s corrective action implementation through the Supplier Corrective Action (SCAR)process; Serve as the main Quality approver for SCARs.
- Evaluate and disposition rejected material, as required.
- Complete audits of suppliers’ quality management systems
- Use statistical analysis and risk management techniques to analyze quality data to identify trends and implement actions as needed. Preparation of QA reports.
- Provide guidance for process changes, including guidance on requirements for supplier and part’s qualification
- Lead CAPA investigations, as required
- Assist Quality Director in establishing, implementing, and maintaining the quality management system
- Provide support during 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
- Bachelor’s degree in Science or Engineering field of study
- 8-10 years of successful experience as a Supplier Quality Engineer in the Medical Device/ Biotech industries, and successful demonstration of responsibilities and knowledge as listed above
- Detailed knowledge of FDA Quality System Regulations (QSR, 21 CFR part 820) and ISO 13485 Regulation
- Strong Technical Writing ability including Microsoft Office proficiency
- Experience using problem solving techniques and conducting CAPA investigations
- Strong organizational skills and ability to prioritize
- Ability to make decisions and communicate effectively to multiple levels
- Supplier auditing experience
- Willingness to travel (approximately 20% Travel)
- SAP Experience
- FDA Audit experience, preferred
- Certified Quality Engineer (CQE), preferred
- Certified Quality Auditor (CQA)/Lead Auditor Certification, preferred
- Six Sigma Certification, preferred
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 COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:
1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR
2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.
(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.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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