Scientist I
Siemens Healthcare Diagnostics Inc.

Job Info

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

This position is a Quality Control function in which the Scientist will work with a team of scientists to ensure timely release of intermediate and finished good products. This facility manufactures and releases products related to the Siemens Diabetes and Urinalysis medical device product lines. Assurance of compliance with all regulatory standards and regulations as well as compliance with all corporate policies and guidelines is required.

Major Job Responsibilities

• Performs a wide variety of assignments according to established procedures, including but not limited routine and moderate tests/analyses, data review and analysis, as well as panel and solution preparations
• Completes preparation of product release reports
• Reviews documentation generated by the lab prior to release to ensure accuracy and completeness
• Provides inputs used for the purpose of control charting and trending of data collected through the release process
• Ensures compliance of current procedures and processes and as needed reviews and updates documentation
• Communicates issues encountered in the lab to initiate the investigation phase as well as aids in troubleshooting process with the lab supervisor
• Participation in validation activities for equipment qualifications and process implementations
• Completes audit of lab instrumentation
• Ensures lab inventory tracking is up to date and orders supplies as needed

Required Knowledge/Skills and Experience

• Experience working with analytical instrumentation, reagent systems, including testing repetitively.
• Experience performing data analysis and some familiarity with statistical analysis tools.
• Experience with immunoassay-based technologies.
• Comfortable in handling of bio-hazardous materials.
• Well-developed written and verbal communication skills
• Solid interpersonal and collaboration skills
• Ability to work in a fast paced environment, working well independently or in a team environment
• Typically 1-2 years of successful experience in quality processes and knowledge of quality related processes and systems
• Knowledgeable of 21 CFR Part 820 regulations and ISO 13485 standard requirements
• General knowledge of process validation

Education
BS in chemistry or biology or equivalent combination of education and experience.

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://jobs.siemens-healthineers.com/careers

If you wish to find out more about the specific division before applying, please visit: https://usa.healthcare.siemens.com/about .

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