Quality Engineer, Prenatal

Quality Engineer, Prenatal Lab Operations

We are seeking a Quality Engineer with a strong background in the LDT environment and expertise in lab practices, bioinformatics, report automation, assays, and reagents. The role involves identifying, developing, and executing process improvements while collaborating with cross‑functional teams across Lab Operations, Bioinformatics, Process Engineering, Software Engineering, and R&D.

• Collaborate with cross‑functional teams to monitor operations, investigate issues, perform changes, and identify improvements.
• Drive occurrence management activities, including Nonconformances, CAPAs, Deviations, and Complaints.
• Develop and maintain quality assurance programs and systems to ensure compliance with regulatory requirements (CLIA, CAP, NYSDOH, etc.).
• Provide training, partnership, and mentorship to laboratory staff and cross‑functional personnel on quality processes and best practices.
• Qualify technical requirements, design specifications, risk management, validation, and verification protocols and documents as part of laboratory operations, change control, and new product development.
• Support the internal audit program and continuous improvement processes.
• Track quality KPIs, analyze trends, and produce metrics reports or presentations with discussion and conclusions.
• Contribute to additional QMS functions as needed, including supplier quality.
• Maintain compliance with applicable FDA, CLIA, CAP, and ISO requirements and related guidances.

• Bachelor’s degree in a scientific or technical field.
• Minimum of 5 years of experience in LDT industry with familiarity with CLIA, CAP, and state‑specific LDT regulations. Equivalent or additional experience in medical device regulation under FDA and ISO acceptable.
• Passion for mentoring early‑career quality peers and championing quality culture cross‑functionally.
• Expertise in quality tools and practices, quality management systems, and continuous improvement methodologies.
• Comfortable navigating ambiguity and shifting priorities in a high‑growth environment using proactive and creative thinking.
• Strong project management skills with a track record of driving cross‑functional initiatives to completion.
• Ability to drive results within established timelines, communicate effectively both in writing and verbally, and work independently and collaboratively.

• Expertise in Quality Improvement such as Lean, Six Sigma, and Root Cause Analysis.
• Expertise in Product Quality such as Design Control, Risk Management, and Usability.
• Experience in Software Quality and related practices such as Agile/Scrum.
• Experience in practical teaching of topics relevant to this role and industry.
• Knowledge of ISO 13485, ISO 14971, ISO 15189, IEC 62304, IEC 62366, and ISO/IEC 42001.
• Familiarity with electronic quality management systems (e.g., Arena, Medialab).
• Familiarity or expertise with data visualization tools (e.g., Tableau).
• Quality or Project Management certifications.

For this position, we offer a total compensation package of $172,379 per year, including a base pay range of $123,262 – $133,981 per year.

• Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80%.
• Extremely generous Family Bonding Leave for eligible employees (16 weeks, paid at 100%).
• Supplemental fertility benefits coverage.
• Retirement savings program including a 4% Company match.
• Increase paid time off with increased tenure.
• Latest and greatest hardware (laptop, laboratory equipment, facilities).
• Free daily on‑site lunches.
• A variety of on‑site perks (state‑of‑the‑art gym, restaurant).
• Free on‑site EV charging (compatible with all EVs).

Billion To One  is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.