Manager of Compliance Testing and Assurance

Position Overview The Manager of Regulated Equipment is responsible for the enterprise-wide management, maintenance, calibration, validation, and regulatory compliance of all regulated equipment and temperature monitoring systems utilized in the collection, processing, storage, testing, transportation, and distribution of blood and blood products. This position ensures all regulated equipment operates in compliance with FDA Current Good Manufacturing Practices (cGMP), AABB standards, internal quality requirements, and all applicable federal and state regulations. This role provides strategic and operational leadership for the organization’s metrology and regulated equipment programs, including preventive maintenance, calibration management, validation activities, temperature monitoring systems, documentation control, vendor coordination, and audit readiness. The Manager of Regulated Equipment oversees the Metrology Technician position and serves as the subject matter expert for regulated equipment compliance throughout the organization. The Manager of Regulated Equipment supports compliance with FDA regulations including, but not limited to, 21 CFR Part 606, specifically §606.60 regarding equipment observation, standardization, calibration, maintenance, and documentation requirements for blood establishments. Essential Functions Regulatory Compliance and Quality Systems * Oversees enterprise-wide compliance for all regulated equipment associated with blood collection, processing, testing, storage, transportation, and distribution * Ensures compliance with FDA regulations, including 21 CFR Part 606, AABB standards, CLIA requirements, OSHA regulations, and applicable state regulations * Develops, implements, and maintains policies, procedures, validation protocols, preventive maintenance schedules, calibration schedules, and associated documentation for regulated equipment systems * Maintains inspection readiness for FDA, AABB, CLIA, state, and internal quality audits * Coordinates responses and corrective actions related to equipment deficiencies, audit findings, deviations, CAPAs, and quality events * Collaborates with Quality Assurance and Operational leadership to ensure equipment systems support regulatory compliance and product integrity * Maintains documentation in accordance with cGMP requirements and document retention standards * Ensures equipment records, maintenance logs, calibration reports, temperature records, validations, and certifications are complete, accurate, and audit ready   Equipment Management * Oversees all regulated equipment used throughout the organization including, but not limited to: * Blood bank refrigerators and freezers * Plasma freezers and thawing equipment * Platelet incubators and agitators * Refrigerated and laboratory centrifuges * Temperature monitoring systems, Isensix® wireless monitoring sensors, gateways, and probes * Data loggers and continuous monitoring systems * Blood collection mixers and scales * Hemocues and laboratory testing equipment * Water baths and warming devices * Controlled room temperature monitoring systems * Transport coolers and shipping validation systems * Irradiators and sterilization equipment when applicable * Additional FDA-regulated or quality-critical equipment * Oversees preventive maintenance, repairs, troubleshooting, calibration, standardization, and validation of regulated equipment * Ensures all regulated equipment performs within validated operating parameters and manufacturer specifications * Coordinates vendor services, third-party calibration providers, warranty repairs, and service agreements * Evaluates and approves new regulated equipment, technologies, monitoring systems, and validation requirements * Develops equipment lifecycle replacement plans and capital equipment recommendations * Maintains enterprise equipment inventory and asset management systems for regulated equipment * Oversees installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities as required * Ensures temperature mapping and environmental qualification studies are completed and documented as required * Reviews and approves calibration standards and traceability documentation to ensure NIST traceability where applicable   Temperature Monitoring Program * Oversees enterprise temperature monitoring and alarm management systems for all regulated storage environments, including the Sensitech Isensix® continuous temperature monitoring platform and associated wireless sensor network infrastructure * Manages installation, qualification, calibration, maintenance, validation, troubleshooting, and lifecycle management of Isensix temperature sensors, gateways, probes, monitoring software, alarm systems, and cloud-based monitoring platforms * Ensures Isensix monitoring systems maintain continuous environmental monitoring compliance for blood products, reagents, laboratory environments, refrigerators, freezers, platelet incubators, transport containers, and controlled room temperature environments * Oversees documentation, alarm response procedures, escalation protocols, user access management, and audit trail reviews associated with Isensix monitoring systems * Oversees enterprise temperature monitoring and alarm management systems for all regulated storage environments * Ensures continuous monitoring systems maintain compliance with blood product storage requirements * Oversees calibration and certification of all temperature probes, monitoring devices, and recording systems * Reviews temperature excursion investigations and assists with corrective and preventive actions * Ensures appropriate backup systems, alarm notifications, and contingency procedures are maintained * Assists with validation and qualification of transport containers and shipping systems   Leadership and Operational Support * Supervises and develops Metrology Technician personnel responsible for metrology, calibration, preventive maintenance, regulated equipment support activities, and temperature monitoring systems * Provides training and technical guidance to operational staff regarding proper use, monitoring, inspection, and documentation of regulated equipment * Coordinates equipment support for fixed sites, mobile operations, laboratories, and blood distribution activities * Collaborates with Facilities, Quality, Laboratory, Operations, Supply Chain, and Information Technology departments regarding regulated systems and equipment * Assists with business continuity and emergency preparedness planning related to regulated equipment and storage systems * Develops departmental operational and capital budgets related to regulated equipment management * Monitors departmental expenses and recommends cost-effective equipment and service solutions * Participates in after-hours response for critical equipment failures, temperature excursions, or emergency operational support when required   Other Duties * Other duties as assigned. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.   Minimum Qualifications * Bachelor’s degree in Biomedical Engineering, Engineering Technology, Facilities Management, Life Sciences, Healthcare Technology Management, Industrial Technology, or related field preferred * Minimum of five years of experience in regulated equipment maintenance, metrology, calibration management, biomedical equipment support, laboratory equipment management, blood banking, pharmaceutical manufacturing, healthcare engineering, or related field * Supervisory or leadership experience preferred * Experience working in FDA-regulated, cGMP, healthcare, laboratory, pharmaceutical, biologics, blood banking, or similar regulated environments preferred * Knowledge of FDA regulations, AABB standards, calibration methodologies, equipment qualification, validation principles, and quality systems * Understanding of temperature monitoring systems, environmental monitoring, and alarm management systems * Knowledge of preventive maintenance systems, computerized maintenance management systems (CMMS), and asset management practices * Ability to read and interpret technical manuals, specifications, engineering documents, calibration reports, and regulatory standards * Knowledge of NIST traceability and metrology principles preferred * Strong troubleshooting, analytical, organizational, and problem-solving skills * Excellent written and verbal communication skills * Ability to establish and maintain effective working relationships with staff, vendors, regulatory inspectors, and management * Knowledge of Microsoft Office applications and computerized equipment management systems * Valid Driver’s License with no major infractions and dependable transportation * Ability to travel between facilities and collection operations as needed   Physical Demands The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Lifting and/or pulling/pushing up to 50 pounds occasionally * Sitting, standing, or walking for extended periods of time * Bending, twisting, kneeling, climbing, and crawling * Ability to work around laboratory equipment, mechanical systems, and mobile operations environments * Ability to respond to equipment emergencies and environmental alarms when required

About the Team The Senior Manager of Application Security leads a global team responsible for embedding security into Miro’s Software Development Lifecycle (SDLC)—from concept to code to customer impact. This team partners closely with product and engineering to proactively mitigate risk while accelerating developer velocity and innovation.The role focuses on enabling secure-by-default development through secure design support, automated tooling, vulnerability management, offensive testing, and developer engagement. It also plays a critical role in integrating security into Miro’s Discover, Define, Deliver product lifecycle and aligning with our AMPED Ways of Working (Analytics, Marketing, Product, Engineering, Design) and AMPED Operating Model. As Miro embraces AI-supported software development and explores Agentic AI workflows that empower engineers, product teams, and security teams alike, this role will contribute to adapting and securing those evolving working methods—ensuring that innovation and trust go hand in hand. About the Role As Senior Manager of Application Security, you will define and operationalize Miro’s application security strategy in alignment with our industry-leading software development lifecycle and AMPED framework. You will lead a multidisciplinary team of application security engineers and offensive security specialists who work directly with developers, product teams, and platform engineering across multiple regions. You will embed security into all phases of the product lifecycle—from early discovery and architecture threat modeling, to design reviews and secure delivery pipelines, and ongoing monitoring and testing post-release. Your team will also support Miro’s AI-driven development tooling and guide secure adoption of Agentic AI workflows, which enable both developers and security teams to collaborate more efficiently and proactively. The role requires a pragmatic, hands-on leader who thrives in fast-moving environments and has a deep understanding of both software engineering and security, as well as a passion for empowering teams to build securely and autonomously. What you’ll do * Lead and mentor a globally distributed team of security engineers focused on application security, offensive testing, secure architecture, and vulnerability remediation. * Lead and coordinate the team's initiatives and help provide project management leadership to the team members. * Coordinate cross function and cross stream initiatives and projects. * Drive integration of security into Miro’s Discover, Define, Deliver lifecycle through the lens of the AMPED Ways of Working and Operating Model. * Collaborate with Product, Engineering, and Design to ensure security is considered at the earliest stages of ideation—via threat modeling, risk reviews, and abuse-case analysis.Shape and evolve Miro’s Secure SDLC practices, integrating security seamlessly into CI/CD pipelines, infrastructure-as-code, and developer tooling. * Oversee execution of bug bounty and third-party testing programs, ensuring vulnerabilities are triaged, communicated, and remediated effectively. * Build and scale Miro’s Security Champions program to embed security ownership within each engineering team. * Guide secure adoption of AI-augmented software development tools, including LLMs used for code generation, reviews, or architectural assistance. * Help envision and safely operationalize Agentic AI-driven developer and security workflows, including policy-driven autonomous agents supporting security automation and decision-making. * Provide structured guidance, patterns, and reference architectures that support developers in implementing secure, scalable, and privacy-respecting features. * Define and report on KPIs and success metrics for secure development adoption, vulnerability resolution, and developer engagement. * Collaborate with Privacy, Legal, and Compliance teams to ensure alignment with regulatory requirements (ISO 27001, SOC 2, GDPR, and emerging AI regulations). * Foster a strong team culture based on collaboration, learning, and continuous improvement. What you’ll need * 10+ years of experience in software, application, or product security, including significant experience in secure software development. * 3+ years of technical leadership or management experience in a security-focused role. * Extensive experience with threat modeling methodologies (e.g., STRIDE, PASTA) and risk assessment, particularly within a SaaS or product-centric organization. * Deep expertise in Secure Software Development Lifecycles (SSDLC), including integrating security into agile and custom development frameworks. * Demonstrated experience running Security Champions programs and scaling developer engagement. * Experience leading offensive security programs (penetration testing, red teaming, bug bounty). * Practical understanding of governance and assurance frameworks such as ISO 27001, SOC 2, and OWASP SAMM. * Familiarity with AI/LLM tooling (e.g., Cursor, GitHub Copilot, custom LLM integrations) and the associated security and governance considerations. * Experience working with AWS and securing API-driven, microservice-based architectures. * Ability to manage distributed teams and communicate effectively across technical and business stakeholders. Who You Are (Skills & Attributes) * Developer-Aligned: You understand the pace and pressure of modern software development and are committed to reducing friction while improving security posture. * An Exceptional Communicator: You can articulate complex technical risks to non-technical stakeholders and translate business goals into security strategy for your team. * A Natural Collaborator: You excel at building strong relationships and influencing cross-functional teams without direct authority. * A Pragmatic Problem-Solver: You are skilled at identifying scalable, risk-based solutions and are comfortable navigating ambiguity in a fast-paced environment. * Data-Driven: You use metrics and KPIs to measure the effectiveness of your programs and drive continuous improvement. * A Passionate Mentor: You are dedicated to developing talent and empowering engineers and product managers to be security champions. Why Join Miro’s Security Team? As a member of Miro’s security leadership, you’ll help define how innovation and trust scale together. You’ll work across the AMPED operating model, empower developers through secure tooling, and support cutting-edge AI-driven and agentic workflows that redefine how software and teams are built. If you thrive on technical depth, cross-functional collaboration, and advancing the next era of secure software development, this role is for you. What's in it for you We want you to feel supported, connected, and ready to grow. Our global benefits package generally includes equity, a wellbeing benefit, a WFH equipment allowance, and an annual Learning & Development stipend. Join a diverse team where you can do your best work. Full benefits may differ per location. If you would like to learn more about location-specific benefits, please refer to our Global Miro benefits board.