Quality Assurance Engineer

Work Schedule

Environmental Conditions

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 beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Join Thermo Fisher Scientific's team for meaningful global impact every day with colleagues dedicated to advancing science solutions for global challenges.

We have industry leading Genetic Science research and development and manufacturing facilities providing solutions to take industry leading products from NPI to the market.

Provide Quality oversight for processes and projects, perform compliance assessments, develop the use of AI within Quality, perform internal audits, and ensure compliance to current regulations.

• Conduct facility, personnel, documentation quality assessments to find errors, ensure compliance with site procedures, ISO 9001 and 13485.
• Provide Quality Assurance support for the development and post-market support activities for consumable, hardware, and software products that support Genetic Science and Next Generation Sequencing applications.
• Lead product transfer, evaluate non-conformances, investigate customer complaints, develop CAPAs, improve processes & systems, and drive sustaining activities.
• Participate in rapid response processes and provide support for deviation events.
• Ensure reporting of critical issues related to deviation events to the appropriate area and quality management.
• Perform quality review and approval of procedures, training documents, and forms of moderate to high complexity.
• Conduct quality reviews and approvals of deviations and process and engineering change controls.
• Serve as the quality assurance representative in Root Cause Analysis to support investigations.
• Conduct daily reviews of key performance quality metrics.
• Perform quality internal audits and resolve identified non-conformities.
• Aid in identifying continuous improvement opportunities.
• Participate in practical process improvement (PPI) initiatives.

• Bachelors Degree required, Science field preferred.

• 2+ years Quality Assurance experience in biotech, Quality background
• Great Written & Communication Skills
• Problem-solving & Root cause analysis
• Understanding of ISO requirements- internal audit experience

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.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards