Quality Engineer II
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Job Location:
Austin, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step further by developing solutions to some of the worlds toughest challenges such as protecting the environment ensuring food safety and finding cures for cancer.
Location/Division-SpecificInformation:
Austin TX. Relocation assistance is NOT provided.
*Must be legally authorized to work in the United States withoutsponsorship.
*Must be able to pass a comprehensive background check which includes a drug screen.
Discover Impactful Work:
Join Thermo Fisher Scientifics Quality Assurance team and contribute to our mission to make the world healthier cleaner and safer. As a Quality Engineer II you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. Youll collaborate with cross-functional teams to drive continuous improvement initiatives lead investigations and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.
Keys to Success:
Education and Experience
- Bachelors Degree required.
- 2 years of quality assurance experience in GMP/ISO regulated environments required.
- Experience in a Medical devices pharmaceuticals or biotechnology environment preferred.
- ISO 13485/FDA Lead Auditor certification is beneficial.
- ASQ certification (CQE CQA)is advantageous.
- Strong knowledge of quality systems cGMP regulations and standards including ISOCFR Part 820.
- Expertise in quality tools and methodologies including risk management root cause analysis CAPA and change control.
- Demonstrated experience leading investigations analyzing quality data and implementing effective corrective actions.
- Excellent documentation and technical writing skills for developing SOPs protocols and reports.
- Strong proficiency in quality management software (TrackWise SAP QM etc.) and Microsoft Office suite.
- Experience conducting internal audits and supporting external regulatory inspections.
- Experience with incoming and final inspection sampling plans and approval workflows.
- Demonstrated ability to build consensus and collaborate across functions.
- Strong verbal and written communication skills.
- Ability to work independently while contributing effectively in team environments.
- Strong attention to detail with analytical and problem-solving capabilities.
- Experience with statistical analysis tools and quality metrics reporting.
- Project management skills and the ability to prioritize effectively.
- Ability to work in clean room environments when required.
- Foreign language skills are beneficial.
Benefits:
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
