Senior Design QA Engineer

Thermo Fisher Scientific • $83K — $111K *

Frederick, MD 21702In-Person

Pharmaceuticals & Biotech

Less than 5 years of experience

2 weeks ago

By clicking Apply, I agree with Ladders' Terms of Use and Privacy Policy

Job Overview by Ladders

Qualifications

Bachelor's degree in Engineering or Science (Chemistry, Microbiology, Genetics, Biochemistry, or related)
4+ years in Quality Assurance (QA, QC, NPI)
4+ years in a regulated industry (pharmaceutical, medical device, or biotech)
Understanding of product development lifecycles
Experience with companion diagnostics (CDx) is a plus

Responsibilities

Lead design control activities for new product introductions (NPI) of Companion Diagnostics (CDx)
Ensure compliance with regulatory requirements and internal quality standards
Establish and maintain quality standards and promote continuous improvement
Participate in team projects and facilitate sub-teams as required
Conduct design reviews and manage risk throughout the product development process

Benefits

Choice of national medical and dental plans, and a national vision plan
Employee assistance and family support programs, including tuition reimbursement
At least 120 hours of paid time off (PTO) and paid parental leave
Retirement savings programs, including a competitive 401(k) plan
Employee Stock Purchase Plan (ESPP) to purchase company stock at a discount

Full Job Description

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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

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
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

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.

Learn more about Thermo Fisher Scientific

Size

130,000 employees

Market Cap

$213.3 billion

Industry

Pharmaceuticals & Biotech

Net Income

$6.3 billion

Founded

1956

5 Year Trend