Senior Design QA Engineer
Thermo Fisher Scientific · Austin, TX · 5 days ago
On-siteQuality Assurance$83k–$111k/yrFull-time
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Environmental Conditions
Office
Keys to Success
- Bachelor’s degree in Engineering or Science field (Chemistry, Microbiology, Genetics, Biochemistry, or related)
- 4+ years of experience in Quality Assurance (Quality Engineering, QA, QC, Supplier Quality, or NPI)
- 4+ years of QA experience in a regulated industry (pharmaceutical, medical device, or biotech) preferred
- Demonstrated understanding of product development lifecycles, design change and change control, product validation methodologies, and manufacturing/product process control methodologies
- Experience with companion diagnostics (CDx) and clinical integration is a plus
Knowledge, Skills, Abilities
- Strong knowledge of cGMP, ISO 13485/14971, IEC 62366, EU IVDR, and applicable regulatory requirements (FDA, EMA, etc.)
- Proficiency with quality management systems and MS Office tools
- Strong analytical, problem-solving, and troubleshooting skills
- Excellent communication and interpersonal skills
- Ability to work independently and collaboratively
- Strong attention to detail with the ability to maintain a broad perspective
Other
- Must be legally authorized to work in the United States without sponsorship now or in the future
- Must be able to pass a comprehensive background check and drug screen
Compensation And Benefits
- Salary Range: $83,300.00–$111,100.00
- Variable annual bonus based on company, team, and/or individual performance results in accordance with company policy
- Total Rewards Package:
- 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
- Retail 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