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)
Ensure that products are designed, developed, and validated in compliance with regulatory requirements and internal quality standards
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

Bachelor’s degree in Engineering or Science field (Chemistry, Microbiology, Genetics, Biochemistry, or related)
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
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
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.

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

Senior Design QA Engineer

Key skills