Quality Support

Job Description

Organization: Siemens Healthineers
Business Unit: Point of Care
Requisition Number: 247830
Primary Location: United States-Indiana-Mishawaka
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: No

Job Description:

Position Overview:

Are you the ready to work in a fast-paced manufacturing environment with cross-functional focus?  You will be involved in supporting a newly established reagent manufacturing system as well as future integration projects within an Immunoassay product line.



·        Site administration of document control system, employee training, and batch and/or batch releasing for immunoassay product line.

·        Support design transfer of new production coming into the facility, including validations, process controls, procedures, process monitoring, and other commissioning activities.

·        Perform procedural review and approvals.

·        Troubleshoots and resolves problems associated with document control system tool.

·        Completes a wide variety of complex administrative assignments.

·        Obtains, correlates, and analyzes technical information needed to complete batch records.

·        Meets with Quality Assurance personnel to establish production requirements for material

      presented to customers and others.

·        Completes the preparation of reports, charts, graphs, and other documents as necessary.

·        Coordinates and facilitates the maintenance of the archive room for all controlled documents.

·        Lead responsible for organizing and maintaining key technical manuals.

·        Works collaboratively in a cross-functional team of Engineers, Manufacturing and Scientists from multiple groups.

·        May lead meetings when assigned to continue projects either for scheduling, batching, document control or employee training.

·          Maintains employee training database.

·          Collaborates with regulatory affairs team to ensure all country specific requirements are maintained in SAP for batch release.

·        Interact with multiple functions across sites including Engineering, Manufacturing, Technical Operations, and Regulatory Compliance.


Required Knowledge/Skills, Education, and Experience

·        B.A. or B.S. Organizational Management or equivalent experience

·        Thorough understanding of MDSAP country standard requirements for medical device or pharmaceutical operations.

·        Experience working with Immunoassay based technology, specifically involving a troponin assay

·        Experience performing data analysis as well as formal report writing.

·        Experience creating and modifying testing protocols and supporting documents.

·        Familiar with document control systems and their administration.

·        Able to work independently and manage tasks assigned on schedule.

·        Strong scientific, communication, and organizational skills are a must.

·        Experience with Microsoft Office Suite for administrative document manipulation.



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



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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, 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.

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