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QMS Manager

Synthbee

Pembroke Pines, Florida

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JOB DETAILS
SKILLS
Aerospace and Defense, American Society for Quality (ASQ), Americans with Disabilities Act (ADA), Auditing, Biology, Certified Quality Engineer (CQE), Code of Federal Regulations, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Document Control, Documentation, External Audit, FDA (Food and Drug Administration), ISO (International Organization for Standardization), ISO 9001, Industry Standards, Internal Audit, Leadership, Medical Equipment, Mentoring, Process Improvement, Product Design, Product Lifecycle, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Risk Management, Root Cause Analysis, Standard Operating Procedures (SOP), Startup, Team Player, Technical Writing
LOCATION
Pembroke Pines, Florida
POSTED
30+ days ago

QMS Manager

Pembroke Pines, FL · Full time

We are looking for a systems-oriented Quality professional 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.


Job 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).
    • Aerospace: AS9100.
    • Automotive: IATF 16949.
  • Design & Product Lifecycle: Experience with Design Controls (DHF, DMR, DHR) and integrating quality from concept through post-market.
  • Experience & Education: 6–10 years of quality experience in a highly regulated technical field; Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • Certifications: ASQ certification (CQE, CQA, etc.) is a significant plus.
  • The "Builder" Mindset: A track record of building or remediating a QMS within a lean or startup environment.
  • Pragmatic Execution: The ability to translate "regulatory-speak" into simple, executable workflows for multi-disciplinary teams.
  • Operational Calm: The ability to remain focused and effective under regulatory pressure and tight growth timelines.
  • Quality Advocacy: Experience acting as a mentor to non-quality teams, ensuring quality is seen as an enabler of growth.

Note: In compliance with the Americans with Disabilities Act (ADA), those functions of the job which are identified essential are required to be performed with or without reasonable accommodations. Requests to facilitate the performance of essential functions will be given careful consideration.

About the Company

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Synthbee