Manager of Regulated Equipment Piedmont)

The Blood Connection•Piedmont, SC

1d•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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
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
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
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
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 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.