The Role
Build, implement, and scale a QMS aligned with ISO 9001; ensure inspection readiness; lead audits and CAPA; perform risk management and root-cause investigations; create SOPs, work instructions, and documentation architecture; mentor cross-functional teams and embed quality across the product lifecycle.
Summary Generated by Built In
QMS ManagerPembroke Pines, FL · Full time
About SynthBee Inc.
Job Description
Required Skills & Technical Competencies: Preferred Qualifications:
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.
- 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.
Skills Required
- Designing, implementing, and maintaining QMS aligned with ISO 9001
- Core competency in regulatory compliance and maintaining inspection-readiness
- Experience leading internal and external audits and managing CAPA responses
- Proficiency in root cause investigation, effectiveness checks, and formal risk management
- Document control and technical writing: drafting SOPs, work instructions, and documentation architecture
- Deep technical knowledge or certification in Medical Device (ISO 13485 & FDA 21 CFR Part 820), Aerospace (AS9100), or Automotive (IATF 16949)
- Experience with Design Controls (DHF, DMR, DHR) and product lifecycle quality integration
- 6-10 years of quality experience in a highly regulated technical field
- Bachelor's degree in Engineering, Life Sciences, or related field
- ASQ certification (CQE, CQA, etc.)
- Track record of building or remediating a QMS in a lean or startup environment
- Ability to translate regulatory requirements into simple, executable workflows
- Experience mentoring non-quality teams and advocating for quality as an enabler
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The Company
What We Do
SynthBee is building a safe, scalable, and reliable computing intelligence platform, known as Collaborative Intelligence™, to amplify and accelerate human innovation. The company provides a safe alternative to Artificial General Intelligence (AGI), focusing on mission-critical systems across sectors such as healthcare, defense, aerospace, automotive, and robotics to help enterprises solve complex scientific, engineering, design, and creative challenges.
