When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons – with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our dedication to you and our 90,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building an exciting career with us.
Location/Division Specific Information
Austin, TX.
Engineer II, QA.
How will you make an impact?
The role of Quality Engineer supports, strengthens and advances the Quality mission, which is enabling our customers to make the world healthier, cleaner, and safer by continuously improving the quality of our products and services. The Quality Engineer will work with various team members, both internal and external customers, with a high degree of integrity. This is a very hands-on collaborative role.
What will you do?
Help to ensure the site meets requirements for ISO 9001, ISO 13485, 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA), Quality Systems Regulation (QSR), and USDA regulations.
Collaborate with interdepartmental contacts on investigations, root cause analysis, and corrections/corrective actions to ensure accurate documentation and closure. Analyze and trend data to identify deficient areas and initiate quality improvement projects
Review and archive validation records
Support NPI projects ensuring design control requirements are met
Prepare clearly written business communications, including audit reports, gap assessments, validations. Participate in internal audits third-party audits, external customers, and Agency inspections as needed
Find opportunities for continuous improvement of the Quality Systems and drive implementation
Serve as a backup for other Quality positions as needed. Fulfill duties to support the quality and regulatory department as assigned.
How will you get here?
Experience
3-5 years in a regulated manufacturing or quality environment
Experience with SAP, Agile and TrackWise preferred
High level of proficiency in Excel
Knowledge, Skills, Abilities
Meticulous and accurate while maintaining a vision of the end result
Strong written and oral communication skills. Acquires solutions through independent analysis.
At Thermo Fisher Scientific, each one of our 90,000 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.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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