Senior Quality & Project Engineer

Columbus, Ohio, United States


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Type: Permanent

Experience: Experienced Professional (Non-Manager)

Education: Bachelor's Degree

Category: Quality Assurance / Safety

Industry: Healthcare / Medical Devices

Company: Centricity Search Group

Reference ID: qCc1uu

Date Posted: 02/24/2026

Shortcut: http://jobs.mrinetwork.com/2HWuZJ


Senior Quality & Project Engineer

 

Dublin, OH – Onsite / Hybrid (Local Candidates Preferred)

Full-Time | Medical Device | Robotics + Clinical Innovation

 

We are developing a breakthrough robotic medical device designed to improve patient outcomes and transform how clinicians deliver care. We are seeking a Senior Quality & Project Engineer to build and own our quality system while driving cross-functional project execution across engineering, clinical, and regulatory workstreams.

 

This is a high-impact, hybrid role blending Quality Engineering and Project Management, ideal for someone who thrives in fast-paced early-stage environments, is energized by ownership, and wants to help bring a first-of-its-kind device to market.

 

What You’ll Do

 

Quality Engineering (Primary Long-Term Focus)

  • Lead the development, implementation, and ongoing management of an electronic Quality Management System (eQMS)
  • Ensure compliance with ISO 13485, current FDA regulations and guidance, and conformity to relevant recognized standards such as IEC 62304 and IEC 62366-1
  • Maintain core QMS elements including DHF, DMR/DHR, CAPA, Risk Management Files, document control, and change control
  • Evaluate the current QMS platform and lead migration to an industry-recognized eQMS if appropriate
  • Partner closely with clinical leadership to support readiness for upcoming testing, verification/validation, and future clinical trials
  • Serve as the internal SME for quality requirements and help the team interpret standards as the device evolves
  • Support internal audits and manage relationships with external quality consultants as needed

Project Management (Majority initially; transitions to minority over time)

  • Establish and maintain the single integrated project schedule (“schedule of truth”) across engineering, clinical, quality, and regulatory teams
  • Run recurring milestone meetings, ensuring dependencies, risks, and timelines are clear and aligned
  • Coordinate cross-functional execution, driving follow-through, documentation readiness, and timely decision-making
  • Interface with Jira (reading tickets, understanding software timelines, logging issues) and integrate software progress into broader project planning
  • Apply structured PM methodologies (Six Sigma, Lean, PMP, or similar) to improve visibility, reduce slippage, and increase operational consistency

 

What You Bring

 

Required Qualifications

  • 5+ years of experience in medical devices, including 3+ years directly in Quality Engineering
  • Direct experience with ISO 13485–aligned QMS implementation, ownership, or maintenance
  • Ability to understand, interpret, and apply FDA regulations and relevant recognized standards, including:
  • IEC 62304 – medical device software lifecycle processes
  • IEC 62366-1 – usability engineering
  • Experience supporting products through prototype → product development → regulatory readiness
  • Strong documentation, communication, and cross-functional coordination skills
  • Demonstrated ability to thrive in fast-moving, ambiguous early-stage environments

 

Preferred Qualifications

  • Experience migrating or configuring medical-grade eQMS platforms (e.g., Greenlight, Enzyme, Qualio, MasterControl)
  • Familiarity with robotics, embedded systems, or software-heavy medical devices
  • Experience with Jira, MS Project, Smartsheet, or similar tools
  • Six Sigma Green Belt or Black Belt, PMP, or equivalent PM certification
  • Prior startup or small-team engineering experience

 

Who You Are

  • A builder who enjoys creating systems, structure, and process from the ground up
  • Equally comfortable with big-picture planning and detailed execution
  • A low-ego contributor who thrives in small, high-collaboration environments
  • Adaptable, curious, and energized by solving meaningful, messy problems
  • Motivated by mission-driven work and excited to bring a novel medical device to market

Work Environment & Benefits

  • Onsite required at the Dublin, OH facility, Hybrid may be considered for local candidates (2–3 days onsite weekly minimum)
  • Equity: Stock options 
  • Benefits: Medical, dental, vision, flexible PTO, paid holidays, winter shutdown
  • Relocation support available for candidates moving to the Columbus/Dublin region

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