Operations & Quality Manager

Job Title:
Operations & Quality Manager (Medical Device Startup)

Position Type: Full-Time

Company: Revi Mo

About Revi Mo:

Revi Mo is a startup developing robotic mobility devices to help people with disabilities live independently and reduce the burden on caregivers. We're a passionate, mission-driven team looking for a dynamic and proactive individual to join us as Operations & Quality Manager.

Job Summary

We are preparing for the commercial launch of our innovative medical device. With our 510(k) clearance pathway defined, we are seeking a versatile, execution-focused Operations & Quality Manager to lead and build our operational foundation in Massachusetts.

In this dual-role capacity, you will work to establish a right-sized, compliant Quality Management System (QMS) and manage our initial supplier network. You will collaborate directly with and receive guidance from experienced regulatory experts to prepare QMS and other regulatory documents. This is a rare opportunity for an ambitious professional to gain hands-on, end-to-end launch experience, and directly impact a life-changing product.

Key Responsibilities

• Implement the QMS: Build, organize, and maintain a functional QMS compliant with FDA 21 CFR Part 820 and ISO 13485 standards.
• Draft Procedures: Write, route, issue, and control Standard Operating Procedures (SOPs), Quality Manuals, and daily work instructions.
• Manage Document Control: Own the day-to-day document control process, including routing, review tracking, approvals, and archiving.

Supplier & Internal Operations

• Manage Suppliers: Track, qualify, and evaluate critical manufacturing partners and component suppliers.
• Oversee Quality Control: Monitor internal and external manufacturing processes to ensure strict adherence to technical specifications.
• Handle Deviations: Coordinate and document Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPA), and root-cause investigations.

Regulatory Support

• 510(k) Preparation: Compile, organize, and format technical files and documentation for the upcoming 510(k) submission.
• Expert Collaboration: Execute documentation strategies under the direct guidance and mentorship of seasoned external regulatory consultants.

Qualifications & Experience

Required

• Experience: 2+ years of hands-on quality assurance or operations experience within the medical device industry.
• Regulatory Knowledge: Solid foundation in FDA 21 CFR Part 820 and ISO 13485 regulations.
• Execution Focus: Proven ability to draft high-quality technical documentation, procedures, and reports with exceptional attention to detail.
• Startup Mindset: Highly organized, self-motivated, and comfortable managing multiple priorities in a fast-paced environment.
• Presence: Ability to work onsite at our Massachusetts location to collaborate directly with the core team.

Preferred

• Medical Device Experience: Direct exposure to medical devices and supporting FDA submission preparations.
• Auditing: Experience participating in supplier audits, internal audits, or FDA/Notified Body inspection readiness.
• Education: Bachelor’s or higher degree in Engineering, Life Sciences, or a related technical discipline.

What We Offer

• Competitive Compensation: Base salary plus benefits and early-stage equity options.
• World-Class Mentorship: Direct, hands-on guidance from veteran medical device regulatory and operations experts.
• Career Growth: A high-visibility management role where your work directly shapes the company's foundation and product commercialization strategy.
• Benefits: Comprehensive health, dental, and vision insurance [adjust based on your actual startup package].