Engineer II QA

Work Schedule

Environmental Conditions

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

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

Discover Impactful Work:

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

A day in the Life:

• Performs daily quality assessments of facility personnel and documentation both classified and nonclassified areas to uncover errors or deficiencies and assure quality and compliance as required by site procedures and ISO 9001 and 13485 requirements.
• Provide Quality Assurance support for the development and post market support activities for software and bioinformatics products that support Genetic Science and Next Generation Sequencing applications.
• Perform first article inspection of software and bioinformatics deployment to ensure requirements are met
• Communicate and maintain the Quality Management System for software and bioinformatics products
• Participates in rapid response process and provides quality guidance for deviation events
• Ensures escalation of deviation events to the appropriate area and quality management
• Performs quality review and approval of procedures training documents and forms of moderate to high complexity
• Performs quality review and approval of deviation and change control of moderate to high complexity
• Participates as the quality assurance representative in Root Cause Analysis to support investigations of moderate to high complexity
• Conducting daily review of key performance quality metrics
• Performs quality internal audits and resolve identified nonconformities
• Aids in identification of continuous improvement opportunities
• Participates in practical process improvement (PPI) initiatives

Keys to Success:

Education

• Bachelors degree is required. Science or Engineering field preferred.

Experience

• Background in bioinformatics or software development/testing
• 2 years of jobrelated experience
• Quality Assurance experience a plus
• Experience in internal auditing a plus
• Excellence communication and written skills

BENEFITS:

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking 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 longterm 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: