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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, Urinalysis, and Cardiac 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 solution preparations
Completes preparation of product and material 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
Ability to discern colors based on visual color product testing requirements
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
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