Senior Design QA Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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 life cycles, 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 $83,300.00-$.

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: