Senior Design QA Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

About the Role

In this role, you will lead all aspects of the “end to end” design control and new product development lifecycle as a quality core team lead for New Product Introductions (NPIs) for Companion Diagnostics (CDx).

You will ensure that products are designed, developed, and validated in compliance with regulatory requirements and internal quality standards.

Location

This is a fully onsite role based in either of the 3 locations: Austin, TX; Carlsbad, CA; Frederick, MD. Please note that relocation assistance is not provided.

Keys to Success

• Education: Bachelor’s degree in Engineering or Science field (Chemistry, Microbiology, Genetics, Biochemistry, or related)
• Experience: 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
• Knowledge: Companion diagnostics (CDx) and clinical integration is a plus

Skills and 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

Compensation and Benefits

The salary range estimated for this position based in Maryland is $83,300.00–$111,100.00. 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