Quality Support - Diagnostic Devices - 189300

Job description

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.

Responsibilities:

·  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

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time

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