About Cytovale

Job Description

Key Responsibilities

• Define and execute an enterprise Quality strategy that supports regulatory obligations, operational objectives, and long-term growth; establish annual quality objectives and the KPIs used to report progress to executive leadership.
• Lead a multidisciplinary Quality organization spanning Quality Assurance, Quality Engineering, Design Quality, Quality Systems, Process Validation, Incoming Inspection, and the audit program.
• Set the strategy for quality infrastructure, including eQMS evolution and the application of AI and analytics to quality processes.

• Serve as Management Representative; own the effectiveness of the QMS and its core processes, including CAPA, nonconformance and deviation management, complaint handling, change control, document control, training, and management review.
• Drive process improvements that allow the organization to move quickly while maintaining full FDA, ISO, and QMSR compliance, with documentation that is cohesive, consistent, and built on continuous-improvement principles.
• Establish and sustain a disciplined operating rhythm for internal audits, annual post-market reviews, and periodic management reviews.
• Maintain a proactive state of inspection readiness and lead the organization through FDA inspections, Notified Body audits, and third-party registration activities.

• Direct design quality assurance across product development and design-change programs, allocating resources, managing budgets, and embedding quality engineers in project teams to ensure efficient, compliant execution.
• Partner with the Senior Director of Regulatory Affairs to develop and maintain a forward-looking 18- to 24-month regulatory roadmap covering letters to file, Special and Traditional 510(k)s, and PCCPs that enable feature and reliability improvements.
• Provide subject matter expertise in design of experiments, process validation, statistical methods, software validation, test method validation and measurement systems analysis, risk management and FMEA, and cybersecurity.

• Own the Quality Improvement Plans for the IntelliSep instrument and associated consumables, and partner with Manufacturing and Engineering on qualification, process capability, and design-transfer activities.
• Govern manufacturing process changes with appropriate validation and documentation and ensure nonconformances are investigated and closed promptly.
• Direct the supplier quality program in collaboration with Supply Chain and R&D, including supplier selection and qualification, audits, performance monitoring, and supplier corrective actions.

• Own the post-market surveillance process end to end, from complaint intake through investigation, trending, product-improvement ticketing, and MDR and vigilance reporting.
• Monitor quality performance through data analysis and trend identification to surface risks early and prioritize improvement initiatives.
• Lead complex investigations and root-cause analyses; strengthen CAPA effectiveness and build organizational capability in structured problem solving.

• Build, coach, and develop a high-performing team of quality engineers, quality professionals, and future quality leaders; foster accountability, engagement, and ownership at every level.
• Champion a company-wide culture of quality through hands-on leadership, cross-functional partnership, and visible participation in QE and QMS activities.

Minimum Qualifications

• Bachelor's degree in engineering discipline.
• 10+ years of progressive quality leadership in the medical device or IVD industry, with 7+ years of experience managing quality teams and organizational performance.
• Demonstrated success leading a QA/RA function at a small- to mid-sized Class II device company, with an 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 both 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).

Compensation