Quality Control Manager

PurposeThe Quality Control Manager ensures that all PortableConnect devices and components meet ROMTech’s quality standards, regulatory requirements, and patient ready criteria. This role oversees all inspection activities, incoming, in process, repair/upgrade, and final release, and ensures consistent, compliant execution across the production lifecycle.The Quality Control Manager provides strategic leadership, manages inspection teams, ensures audit readiness, and drives continuous improvement to reduce defects, eliminate escapes, and support efficient, compliant production.Key Results and MetricsKey Result: Ensures the quality, consistency, and compliance of all ROMTech products across the device lifecycle.Key Performance MetricsInspection throughput and on time completionFirst Pass YieldDefect and escape ratesNonconformance closure timelinessCAPA effectivenessAudit outcomes and readinessRework ratesOn time and compliant device releaseWinning Attitude and MindsetThe Quality Control Manager leads with ownership, integrity, and a patient first mindset. They reinforce disciplined, standardized execution while enabling efficient operations. They expect issues to be escalated early, promote root cause thinking, and cultivate a culture where quality is proactively protected, not inspected in after the fact.Core Responsibilities Quality Oversight & LeadershipLead, coach, and develop the Quality Inspector team.Manage staffing, scheduling, and resource allocation.Ensure inspection consistency and adherence to standard work.Conduct performance reviews and support employee development.Uphold a positive, compliant, and high accountability culture. Inspection Program ManagementOversee incoming, in process, repair/upgrade, and final inspection operations.Ensure inspection coverage aligns with production demand and risk.Maintain inspection standards, sampling plans, and risk based approaches.Serve as approver for device release when required.Address daily line support issues and drive resolution. Compliance & Quality SystemsEnsure compliance with FDA QSR (21 CFR 820), ISO 13485, and internal QMS expectations.Maintain inspection procedures, work instructions, and documentation.Support internal, external, and regulatory audits; lead corrective actions.Partner with Regulatory and Quality Assurance on compliance strategy. Nonconformance & CAPAOversee identification and documentation of nonconforming product.Lead or support root cause investigations.Drive implementation and verification of corrective/preventive actions.Ensure containment and prevent recurrence of defects and quality escapes. Cross Functional CollaborationCollaborate with Production, Engineering, Supply Chain, and Repair teams to resolve issues.Provide quality input for process changes, design changes, and NPI.Support supplier quality efforts and feedback loops related to incoming parts.Escalate systemic risks to leadership with data driven analysis. Continuous ImprovementDrive initiatives to improve yield, reduce rework, and reduce inspection burden through improved processes.Promote automation, standardization, and error proofing solutions.Use data to prioritize and implement quality improvements.Implement risk based inspection strategies and sampling methods. Documentation & ReportingEnsure inspection data is accurate, complete, and traceable.Maintain device history record (DHR) integrity for inspections.Provide dashboards and reporting on key quality indicators.Communicate quality performance and risks to leadership regularly.Patient ImpactThrough strong leadership and rigorous oversight, the Quality Control Manager ensures that every PortableConnect device meets the highest safety, reliability, and performance standards before reaching a patient. Their work minimizes delays, eliminates defects, and reinforces trust in ROMTech’s technology, directly supporting safe, effective recovery experiences.