Description de l'offre
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 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
• 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
• Proficient in Windows-based applications including Microsoft Access and Minitab Statistical Software
• 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
BS in chemistry or biology or equivalent combination of education and experience.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Early Professional
Job Type: Full-time
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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
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