Senior Design QA Engineer

Discover Impactful Work

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.

A Day in the Life

• Work with multiple teams to lead and support design control activities across the full product development lifecycle for CDx NPIs including:
  • User and Product Requirements
  • Design Verification and Validation (V&V)
  • Risk Management
  • Design Reviews
• Ensure activities are conducted in compliance with all applicable regulatory requirements, international standards, and internal procedures
• Establish, maintain, and drive quality standards while supporting a culture of continuous improvement and compliance
• Participate in team projects and assignments, facilitating or leading sub-teams as necessary

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
• 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

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.