Quality Engineer II

About Countable Labs

At Countable Labs, we’re reimagining the future of genomics—and we’d love for you to be a part of it! As the innovators behind our groundbreaking Countable PCR platform, we’re building tools that make a real impact in precision medicine. We’re a fast-growing startup fueled by innovation, collaboration, and a mission-driven spirit. If you’re ready to roll up your sleeves, build something from the ground up, and help shape the future of genomics, we want you on our team!

Role Overview

We are a fast-growing biotech startup developing innovative Research Use Only (RUO) products that combine instrumentation and reagent-based assays. We are seeking a Quality Engineer II to support design control activities and supplier quality as we scale from development into early manufacturing.

This is a contract- to-hire position. This role is hands-on and execution-focused, working closely with R&D, engineering, manufacturing, and external partners (CDMOs and suppliers) to ensure product quality and documentation are established and maintained. While our current products are RUO, this role will help build foundational practices to support future regulatory readiness.

Key Responsibilities

• Quality Systems Support
• Set up audit prep activities doc control, training and design control procedures.
• Assist in building complaint handling procedures- intake, investigation and response.
• Support execution of document control, change control, and CAPA.
• Track and analyze quality metrics (e.g., internal and external defects) and provide insights to leadership to drive continuous improvement.
• Assist in maintaining training records and ensuring compliance for key departments within the organization.
• Collect and maintain accurate and up-to-date quality events across the organization.
• Support post-market surveillance procedures - feedback loops, performance monitoring

CDMO & Supplier Quality

• Support qualification and ongoing management of suppliers and CDMOs.
• Assist in supplier evaluations, audits, and performance monitoring.
• Review supplier documentation such as CoAs, deviations, and change notifications.
• Help ensure quality requirements are clearly defined and communicated through specifications and quality agreements.

Manufacturing & Quality Support

• Support incoming inspection, in-process controls, and final product release activities as needed.
• Assist in defining and maintaining product specifications and acceptance criteria.
• Participate in investigations (nonconformances, deviations, complaints) and support root cause analysis and corrective actions.
• Help ensure appropriate documentation and traceability for builds and testing activities.
• Collaborate with cross-functional teams to address supplier-related quality issues.

Product Design & Development Quality

• Support implementation of design control activities, including design inputs/outputs, verification, validation, and design reviews.
• Collaborate with R&D and engineering to ensure requirements, specifications, and test plans are clearly defined and documented.
• Review and support approval of development documentation (protocols, reports, design history file (DHF) content).
• Assist in risk management activities (e.g.FMEA, risk assessments, hazard analysis) and ensure proper documentation.
• Contribute to design transfer activities to ensure readiness for manufacturing.

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Engineering, or a related field.
• ~3–6 years of experience in quality engineering or related roles in biotech, life sciences, or diagnostics.
• Experience supporting design control and/or product development activities.
• Exposure to supplier quality or external manufacturing (CDMO) environments.
• Familiarity with quality systems and documentation practices (e.g., DHF, SOPs, change control).
• Understanding of risk management principles.
• Strong attention to detail and ability to manage documentation in a fast-paced environment.
• Ability to work cross-functionally and communicate effectively.

Preferred

• Familiarity with ISO 13485, FDA QSR, or GMP frameworks
• Experience supporting RUO or early-stage product development
• Exposure to instrumentation and/or reagent-based products