Engineer II, Quality Assurance

Expiring today

Thermo Fisher Scientific
Carlsbad, CA
Jul 30, 2021
Aug 02, 2021
Organization Type
*Job Title:* Quality Engineer II

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

*Location/Division Specific Information*
The Biosciences Division (BID) offers reagents, instruments, and consumables from across the division's six business units. This division is truly grounded in science with our products offering new hope to cancer patients and so much more. BID is a $2.5 billion business with 4,000+ employees across the globe. Our team serves 480,000 customers with 70,000 products in 180 countries.

*How will you make an impact?*
Provide Quality Assurance Support to the Carlsbad site. Help strengthen our quality system and make improvements where needed. Help educate and promote adherence to Quality Assurance policies and requirements. The Quality Engineer will be responsible for driving the execution of quality goals and objectives.

*What will you do?*
• Collaborate across functions, leveraging quality and manufacturing expertise to troubleshoot problems, interpret data, and determine next steps
• Support implementation of secondary suppliers, assist with development of raw material specifications
• Participate in change control activities for documents and manufacturing processes
• Assist with the maintenance of ISO registration and the internal audit program
• Ensure proper use of quality systems and processes
• Provide guidance and direction to ensure ISO/Quality system compliance
• Manage maintenance, completeness, and accuracy of Quality records
• May provide guidance or direction to other personnel such as assistance with prioritization and investigations
• Manage problem requests (nonconformance's), complaint records, and corrective and preventive actions (CAPAs)
• Perform training on Quality procedures
• Create, review and revise quality policies and procedures
• Collect and analyze quality data
• Participate, as needed, on new product teams
• Perform other duties and cross training as assigned

*How will you get here?*

* Bachelors degree required in a scientific (STEM) discipline

• 3-5 years experience in a manufacturing quality environment

*Knowledge, Skills, Abilities*
• High level of proficiency in Excel
• Knowledge in standards and regulations such as ISO 9001, ISO 13485, GMP, 21 CFR Part 820
• Strong written and oral communication skills
• Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
• Detail-oriented and accurate while maintaining a vision of the end result

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

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