Senior Design QA Engineer

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

The salary range estimated for this position based in Maryland is $83,300.00–$111,100.00.
Compensation may vary based on location.

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
• 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