Quality Engineer

Quality Engineer

The Quality Engineer owns and drives Corrective and Preventive Action (CAPA) activities end-to-end, manages Non-Conforming Material Reports (NCMRs), and supports design quality across the product lifecycle with a focus outside manufacturing operations. This role operates with a strong sense of urgency to resolve quality events, identifies and addresses gaps in quality processes, and collaborates closely with Engineering, Regulatory, and Operations teams to improve product quality and patient outcomes.

The position offers the opportunity to take ownership of quality initiatives, build and refine processes, and grow within a collaborative, mission-driven environment.

• Own and drive CAPA activities from initial investigation through root cause analysis, implementation of corrective and preventive actions, and formal closure.
• Manage and resolve Non-Conforming Material Reports (NCMRs), ensuring appropriate disposition and documentation.
• Support design quality efforts across the product lifecycle, with a primary focus on activities outside of manufacturing operations.
• Collaborate cross-functionally with Engineering, Regulatory, and Operations to investigate and resolve quality issues and ensure alignment on quality standards.
• Identify gaps in existing quality processes and proactively propose, develop, and implement improvements.
• Operate with a strong sense of urgency to ensure timely resolution of quality events and minimize impact on products and patients.
• Balance hands-on execution and effective delegation, while remaining directly involved in technical quality work as needed.
• Independently manage quality investigations and CAPA tasks with limited direction, maintaining high standards of documentation and compliance.
• Support both technical execution and process ownership for quality systems and initiatives.
• Contribute to building and refining quality processes in a fast-paced, evolving environment.

• 2–6+ years of experience in Quality Engineering within medical devices or a regulated industry.
• Hands-on experience independently managing CAPAs and conducting quality investigations.
• Experience working with Non-Conforming Material Reports (NCMRs).
• Exposure to design quality principles, with focus not strictly limited to manufacturing or operations.
• Strong problem-solving skills and the ability to think critically through complex quality issues.
• Proven ability to work independently with limited direction while maintaining accountability for results.
• Excellent communication skills, with the ability to clearly convey technical information to cross-functional partners.
• Demonstrated cross-functional collaboration skills with Engineering, Regulatory, and Operations teams.
• Comfort working in fast-paced, evolving environments with a degree of ambiguity.
• Demonstrated ability to quickly ramp up and hit the ground running in new roles.

• Experience working in a Contract Manufacturer (CMO) or small to mid-sized medical device company.
• Prior experience supporting both technical execution and ownership of quality processes.
• Motivation to build and improve quality processes in a growing, innovative organization.
• Interest in contributing to product quality and patient outcomes in a mission-driven setting.
• Ability to balance detailed technical work with broader process improvement initiatives.
• Eligibility for equity upon full-time conversion, subject to company policies.

The role is based in a growing, innovative medical device environment that is fast-paced and evolving, with a culture that values ownership, collaboration, and mission-driven work focused on improving patient outcomes. The team operates with core collaboration hours from 9:00 AM to 3:00 PM, offering flexibility outside of those hours to support work-life balance. You will work closely with Engineering, Regulatory, and Operations in a highly cross-functional setting, with an emphasis on both technical quality execution and continuous process improvement.

The organization uses a work model designed to ensure mutual fit, allowing you to grow into full-time opportunities and…