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- QMS Manager

SynthBee Inc. QMS Manager Pembroke Pines, FL
- Full time Company website

Apply for QMS Manager

We are looking for a systems-oriented Quality skilled to build and scale our quality infrastructure. Whether your background is in MedTech, Aerospace, or Automotive, we value your ability to translate complex requirements into lean, executable workflows. You will ensure our system is a catalyst for innovation rather than a bureaucratic hurdle.

About SynthBee Inc.
At SynthBee we’re building Collaborative Intelligence™ maximising the potential of people and computers working together. CI™ will help humans solve the most important scientific, engineering, design, and creative challenges of our time. And create joy in the process.

Description
Required Skills & Technical Competencies
- QMS Architecture & Implementation: Mastery in designing, implementing, and maintaining a QMS infrastructure aligned with ISO 9001 standards.
- Regulatory Compliance:



Core competency in navigating stringent regulatory environments and maintaining a state of continuous inspection-readiness.
- Audit & Inspection Leadership: Experience leading internal and external audits (notified bodies, registrars, or customer audits) and managing formal CAPA responses.
- Risk Management & CAPA: Proficiency in root cause investigation, effectiveness checks, and formal risk management practices to drive systemic improvements.
- Document Control & Technical Writing: Skilled in drafting high-quality SOPs, work instructions, and documentation architecture from the ground up.

Preferred Qualifications
- Industry-Specific Standards: Deep technical knowledge or certification in one or more of the following:

○
Medical Device:
ISO 13485 & FDA 21 CFR Part 820 (QSR).

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Aerospace:
AS9100.

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Automotive:
IATF 16949.
- Design & Product Lifecycle: Experience with Design Controls (DHF, DMR, DHR) and integrating quality from concept through post-market.
- Experience & Educa

📌 QMS Manager (Nirsa)
🏢 SynthBee
📍 Nirsa