Technical Support Manager

Rhythm Healthcare•Atlanta, GA

7d•$120,000 - $125,000

About The Position

We are hiring a Technical Support Manager who provides quality engineering leadership for field performance, complaint investigations, returned-product evaluation, CAPA, nonconforming product, service quality, and continuous improvement across Rhythm Healthcare’s respiratory and durable medical equipment portfolio. Reporting to the Director of QARA, the role serves as the technical escalation point for complex customer and service issues and converts field feedback into documented, risk-based improvements to products, suppliers, service processes, and the Quality Management System (QMS). The role partners with Customer Experience, Regulatory Affairs, Operations, Supply Chain, Product Management, Commercial, authorized repair centers, and OEM manufacturers. It supports customers through technically accurate troubleshooting, investigation updates, service documentation, and training.

Requirements

Bachelor’s degree in biomedical, mechanical, electrical, industrial, manufacturing, or quality engineering; life science or another technical discipline may be acceptable with equivalent device experience.
Five or more years of progressive experience in medical-device quality engineering, complaint investigation, failure analysis, technical service, manufacturing engineering, or a closely related regulated environment; seven or more years preferred for the Senior level.
Demonstrated hands-on troubleshooting of electro-mechanical medical equipment; respiratory/DME product experience strongly preferred.
Working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, complaint handling, CAPA, nonconforming product, change control, supplier quality, audit readiness, and good documentation practices.
Experience developing defensible investigation reports, controlled technical documents, test methods, and customer-facing technical summaries.
Strong analytical, technical writing, facilitation, training, prioritization, and cross-functional influencing skills.
Proficiency with eQMS, CRM/ticketing and ERP systems, Microsoft Office, and data-analysis tools; experience with NetSuite, Power BI, Minitab, or advanced Excel preferred.

Nice To Haves

Experience supporting FDA, ISO 13485, MDSAP, supplier, or customer audits.
Experience with OEM/contract-manufacturer investigations, authorized repair centers, post-market surveillance, field actions, or product risk management.
Familiarity with HIPAA and data-privacy boundaries when customer or patient information may be encountered
ASQ Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor, or Lean Six Sigma Green/Black Belt.

Responsibilities

Lead or support technically complex complaint investigations and returned-product evaluations; document problem statements, test methods, evidence, root cause, conclusions, and recommended actions.
Analyze complaint, RMA, repair, warranty, ticket, and field-failure data to identify adverse trends, recurring failure modes, emerging risks, and potential product escapes.
Partner with Regulatory Affairs to identify events requiring escalation for MDR assessment, field action, recall, or other regulatory evaluation.
Translate field findings into updates to risk files, service instructions, supplier actions, CAPAs, product improvements, or post-market surveillance inputs.
Serve as the Quality technical escalation point for complex or recurring respiratory and DME product issues after initial Customer Experience triage.
Guide Customer Experience and service personnel on evidence collection, safe troubleshooting boundaries, complaint intake, escalation criteria, and approved customer messaging.
Participate in customer calls or site visits when a significant technical, safety, systemic, or relationship risk requires Quality involvement.
Provide technically accurate investigation summaries and corrective-action updates suitable for customers and internal stakeholders, in collaboration with Regulatory Affairs and Legal/Compliance when applicable.
Create and maintain controlled troubleshooting guides, service bulletins, repair protocols, diagnostic methods, knowledge-based content, and technical training materials.
Define qualification and performance requirements for authorized repair centers; support technical audits, competency assessments, and corrective actions.
Develop and deliver train-the-trainer or advanced service training; measure training effectiveness and use results to improve content and service processes.
Evaluate new products, changes, and service tools for support readiness and ensure service feedback enters design/change and risk-management processes.
Lead CAPA investigations, structured root cause analysis, correction/corrective-action planning, implementation verification, effectiveness checks, aging control, and trend reporting.
Investigate nonconforming product and support containment, disposition, escalation, and material review decisions with Operations, Supply Chain, Regulatory Affairs, and suppliers.
Use appropriate problem-solving and statistical tools such as 5 Whys, fishbone analysis, fault-tree analysis, Pareto analysis, hypothesis testing, and basic SPC.
Develop and revise controlled procedures, work instructions, forms, test methods, service documentation, and quality records in accordance with FDA QMSR, ISO 13485, MDSAP, and applicable internal requirements.
Support internal, supplier, FDA, ISO 13485, MDSAP and customer audits.
Review product, supplier, labeling, service, and process changes for quality and regulatory impact; support change-review decisions and implementation verification.
Support supplier qualification, performance review, audits, SCARs, and technical resolution of OEM or component quality issues.
Support risk management, equipment and test qualification, and quality aspects of new product/service readiness.