Implementation manager • miramar fl
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 tr... Show more
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The average salary range is between $ 83,965 and $ 151,191 year , with the average salary hovering around $ 107,370 year .
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.
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.
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: 610 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.
