Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you'll 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 world's toughest challenges, such as protecting the environment, ensuring food safety, and finding cures for cancer.
Location/Division-Specific Information:
Austin, TX. Relocation assistance is NOT provided.
Discover Impactful Work:
Join Thermo Fisher Scientific's 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. You'll 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
Bachelor's 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 ISO 13485, 21 CFR 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!
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.