Quality Engineer III

• ✓Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance within a regulated industry, such as pharmaceutical, medical device, or biotech
• ✓Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
• ✓ASQ certifications (CQE, CQA) desired
• ✓Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory

(FDA, EMA, etc.)

• ✓Experience with process validation , including protocol execution, process qualification, continued process verification, and validation deviation management
• ✓Experience leading quality and compliance remediation, including gap assessments, corrective actions, effectiveness checks, and remediation plans
• ✓Expertise in quality systems, including:
• ✓CAPA and deviation management
• ✓Change control
• ✓Risk management and FMEA
• ✓Document control
• ✓Internal and external auditing
• ✓Advanced problem-solving and root cause analysis skills
• ✓Excellent project management skills
• ✓Strong verbal and written communication skills
• ✓Proficiency with quality management software and MS Office
• ✓Experience with equipment, process, and cleaning validation
• ✓Knowledge of statistical analysis, process capability, trending, and quality tools
• ✓Ability to work independently and collaboratively
• ✓Strong attention to detail and broad perspective
• ✓Excellent cross-functional collaboration skills
• ✓May require up to 25% travel
• ✓Additional language skills may be beneficial
• ✓Must be able to satisfy applicable pre-employment screening

for the position.

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