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CytoVale is a medical diagnostics company developing the IntelliSep test, a sepsis detection assay that analyzes white blood cell structure to stratify patient risk. The test delivers results in under 10 minutes from a standard blood draw.
The Head of Quality and Regulatory reports to the Chief Operating Officer and owns CytoVale's Quality Management System (QMS) as the designated Management Representative. This is a quality-first leadership role with strong regulatory partnership, accountable for QMS effectiveness and compliance under FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, and applicable IEC standards.
Key responsibilities include:
**Quality Strategy & Leadership**: Define and execute enterprise Quality strategy supporting regulatory obligations and growth; establish annual quality objectives and KPIs; lead multidisciplinary Quality organization spanning QA, Quality Engineering, Design Quality, Quality Systems, Process Validation, Incoming Inspection, and audit programs; set strategy for eQMS evolution and AI/analytics application.
**QMS & Compliance**: Serve as Management Representative; own QMS effectiveness including CAPA, nonconformance/deviation management, complaint handling, change control, document control, training, and management review; drive process improvements enabling speed while maintaining FDA/ISO/QMSR compliance; maintain inspection readiness and lead FDA inspections, Notified Body audits, and third-party registration.
**Design Quality & Regulatory Roadmap**: Direct design quality assurance across product development and design-change programs; partner with Senior Director of Regulatory Affairs on 18–24-month regulatory roadmap covering letters to file, Special and Traditional 510(k)s, and Predetermined Change Control Plans (PCCPs); provide SME expertise in design of experiments, process validation, statistical methods, software validation, risk management, FMEA, and cybersecurity.
**Manufacturing & Supplier Quality**: Own Quality Improvement Plans for IntelliSep instrument and consumables; partner with Manufacturing and Engineering on qualification and design transfer; govern manufacturing process changes; direct supplier quality program including selection, qualification, audits, and corrective actions.
**Post-Market Surveillance**: Own post-market surveillance end-to-end from complaint intake through investigation, trending, product-improvement ticketing, and MDR/vigilance reporting; monitor quality performance through data analysis; lead complex investigations and root-cause analyses.
**People & Culture**: Build, coach, and develop high-performing quality team; foster accountability and ownership; champion company-wide quality culture through hands-on leadership and cross-functional partnership.
**Minimum Qualifications**
- Bachelor's degree in engineering discipline
- 10+ years of progressive quality leadership in medical device or IVD industry
- 7+ years of experience managing quality teams and organizational performance
- Demonstrated success leading QA/RA function at small- to mid-sized Class II device company with emphasis on process and on-market product improvement
- Deep working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, cGMP, and IVD-specific regulatory and quality requirements
- Track record of leading FDA inspections and Notified Body audits and sustaining inspection readiness
- Significant experience leading Quality Assurance and Quality Control organizations, including inspection and test method development and validation
- Applied expertise in risk analysis, FMEA, impact/hazard analysis, statistical methods, and process and software validation
- Proven ability to lead structured problem solving, apply data- and risk-based decision making, and drive sustainable corrective actions
- Experience driving cultural change and building high-functioning cross-functional teams; thoughtful, analytical, and intellectually curious
**Preferred Qualifications**
- MBA or Master's degree in engineering or related field
- Hands-on experience with eQMS platforms and AI-enabled quality tools
- Six Sigma Green Belt or Black Belt certification
- Certified internal auditor (ISO 13485) or comparable ASQ certification (CQA, CQE, CMQ/OE)
