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 Quality Support
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Professional, you will be responsible for:
- You will support site administration of document control system, employee training, and batch and/or batch releasing for immunoassay product line.
- In your activities you will support design transfer of new production coming into the facility, including validations, process controls, procedures, process monitoring, and other commissioning activities.
- You will perform procedural review/approvals and obtains, correlates, and analyzes technical information needed to complete batch records.
- You will perform troubleshoots and resolves problems associated with document control system tool.
- You will complete a wide variety of complex administrative assignments and completes the preparation of reports, charts, graphs, and other documents as necessary.
- You will meet with Quality Assurance personnel to establish production requirements for material presented to customers and others.
- You will coordinate and facilitate the maintenance of the archive room for all controlled document and work collaboratively in a cross-functional team of Engineers, Manufacturing and Scientists from multiple groups.
- You will lead meetings when assigned to continue projects either for scheduling, batching, document control or employee training.
- You will maintain employee training database and responsible for organizing and maintaining key technical manuals.
- You will collaborate with regulatory affairs team to ensure all country specific requirements are maintained in SAP for batch release.
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
- You have deep professional know-how and experience working with Immunoassay based technology, specifically involving a troponin assay
- You have thorough understanding of MDSAP country standard requirements and regulatory authority for medical device or pharmaceutical operations
- You have experience creating and modifying testing protocols and supporting documents.
- You are familiar with document control systems and their administration.
- You are able to work independently and manage tasks assigned on schedule.
- You have experience working in the manufacture of In-Vitro Diagnostic reagents and test kits
- You have strong scientific, communication, and organizational skills are a must
- You have experience with Microsoft Office Suite for administrative document manipulation
Required skills to have for the success of this role
- BS/BA in related discipline, or equivalent combination of education and experience
- Minimum of 3 - 5 years of experience as quality support professional, preferably with a global manufacturer of IVD medical devices
- Must have strong organizational and technical writing skills
- Must have strong communication skills and work well with a team and experience working on multidisciplinary teams in a fast-paced, dynamic environment
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.As an equal-opportunity employer we are happy to consider applications from individuals with disabilities
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Full / Part time: 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.
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.