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Senior Design QA EngineerDormont Manufacturing Company • Frederick, Maryland, United States
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Senior Design QA Engineer

Dormont Manufacturing Company
  • US
    Frederick, Maryland, United States
  • US
    Frederick, Maryland, United States
Apply Now

About

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 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
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  • Frederick, Maryland, United States

Languages

  • English
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