The Scientist I will work as a member of the Mishawaka QCElaboratory group. The purpose of this position is to support all QCE laboratoryfunctions. The Scientist will be required to perform routine testing activitiesin the quality control laboratory supporting Manufacturing needs to ensuretimely delivery of quality products to our customers.

　　This position is a Quality Control function in which theScientist will work with a team of scientists to ensure timely release ofintermediate and finished good products. This facility manufactures andreleases products related to the Siemens Diabetes and Urinalysis medical deviceproduct lines. Assurance of compliance with all regulatory standards andregulations as well as compliance with all corporate policies and guidelines isrequired.

　　Major Job Responsibilities

　　Performsa wide variety of assignments according to established procedures, includingbut not limited routine and moderate tests/analyses, data review and analysis,as well as panel and solution preparations

　　Completespreparation of product release reports

　　Reviewsdocumentation generated by the lab prior to release to ensure accuracy andcompleteness

　　Providesinputs used for the purpose of control charting and trending of data collectedthrough the release process

　　Ensurescompliance of current procedures and processes and as needed reviews andupdates documentation

　　Communicatesissues encountered in the lab to initiate the investigation phase as well asaids in troubleshooting process with the lab supervisor

　　Participationin validation activities for equipment qualifications and processimplementations

　　Completesaudit of lab instrumentation

　　Ensureslab inventory tracking is up to date and orders supplies as needed

　　RequiredKnowledge/Skills and Experience

　　Experience working with analyticalinstrumentation, reagent systems, including testing repetitively.

　　Experience performingdata analysis and some familiarity with statistical analysis tools.

　　Experience withimmunoassay-based technologies.

　　Comfortable inhandling of bio-hazardous materials.

　　Well-developed written and verbalcommunication skills

　　Solidinterpersonal and collaboration skills

　　Ability to work in a fast paced environment, workingwell independently or in a team environment

　　Typically1-2 years of successful experience in quality processes and knowledge ofquality related processes and systems

　　Knowledgeable of21 CFR Part 820 regulations and ISO 13485 standard requirements

　　Generalknowledge of process validation

　　Education

　　BS in chemistry or biology or equivalent combination ofeducation and experience.

　　At Siemens Healthineers,we value those who dedicate their energy and passion to a greater cause. Ourpeople make us unique as an employer in the med-tech industry. What unites andmotivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on ourremarkable legacy of pioneering ideas that translate into even betterhealthcare products and services. We recognize that taking ownership of ourwork allows both us and the company to grow. We offer you a flexible anddynamic environment and the space to move beyond your comfort zone to grow bothpersonally and professionally.

　　If you wantto join us in transforming the way healthcare is delivered, visit our careersite at https://jobs.siemens-healthineers.com/careers

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