Quality Manager

We are seeking a Quality Manager for a high-growth medical device/IVD organization developing innovative solutions to improve diagnostic sample integrity and reliability. This is an excellent opportunity for a hands‑on Quality leader who enjoys building scalable systems in a fast‑paced, regulated environment.

In this role, you will:

• Lead and develop a small Quality team, including coaching, mentoring, and performance management
• Own and evolve the Quality Management System (QMS) to support company growth and regulatory compliance (ISO 13485, FDA QSR, MDSAP, EU MDR)
• Serve as the Quality Systems subject matter expert and ensure eQMS effectiveness
• Oversee core quality processes including document control, change management, CAPA, deviations, and complaints
• Drive investigation quality, root cause analysis, and timely resolution of quality issues
• Lead audit readiness activities and support ISO certification and FDA inspections
• Partner with suppliers and Contract Manufacturing Organizations (CMOs) to ensure quality performance and compliance
• Support training programs to ensure consistent understanding and execution of quality processes
• Collaborate cross‑functionally with R&D, Operations, and leadership to support product and organizational growth
• Identify and implement continuous improvement opportunities across the QMS

• Bachelor’s degree in science, engineering, or related discipline (or equivalent experience)
• 6–9+ years of experience in Quality within medical device or IVD environments
• Strong working knowledge of ISO 13485 and FDA QSR (21 CFR 820)
• Experience supporting FDA inspections and ISO audits
• Prior experience managing CAPA, deviations, change control, complaints, and audit findings
• Experience working with suppliers and/or CMOs in a regulated environment
• Experience in a fast‑paced, scaling organization
• Strong communication skills and ability to influence cross‑functional teams
• Prior leadership experience managing or mentoring direct reports

• ASQ CQA or RAC certification
• Experience in diagnostics or IVD environments
• Exposure to design controls or product development lifecycle
• Experience building or scaling a QMS in a startup or growth‑stage company

Averro is an equal opportunity employer, and we are committed to diversity, equity, and inclusion in the workplace. All qualified applicants will receive consideration for employment, regardless of criminal histories, consistent with legal obligations. All employment decisions shall be made without regard to age, race, creed, color, religion.