Technical Support Manager

Rhythm Healthcare, LLC; Atlanta (GA); On-site; USD 120,000 - 125,000; Full time

Job summary

Rhythm Healthcare, LLC is seeking aTechnical Support Manager to lead quality engineering for field performance, complaint investigations, and post-market surveillance across respiratory and DME portfolios. You will drive CAPA, risk management, and service process improvements.

Reporting to the Director of QARA, you will partner with Regulatory Affairs, Operations, Product Management, and suppliers to deliver technically precise investigations, training, and documentation that support compliant,

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical, industrial, manufacturing, or quality engineering.
• Five or more years in medical-device quality engineering, complaint investigation, or related regulated environment; seven+ years for Senior level.
• Hands-on troubleshooting of electro-mechanical medical equipment; respiratory/DME experience preferred.
• Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, CAPA, nonconforming product, change control, supplier quality, audits, and documentation.
• Experience developing defensible investigation reports and customer-facing technical summaries.
• Strong analytical, writing, training, and cross-functional influencing skills.

Responsibilities

• Lead or support complex complaint investigations and returned-product evaluations with documentation.
• Analyze data to identify trends, risks, and product escapes; coordinate with Regulatory Affairs on MDR and recalls.
• Translate field findings into updates to risk files, CAPAs, service instructions, and post-market inputs.
• Develop and deliver training materials, service bulletins, and knowledge content.
• Support audits, supplier qualifications, and risk management activities.

Skills

Troubleshooting electro-mechanical

Power BI

Minitab

Advanced Excel

NetSuite

ERP systems

CRM/ticketing

FDA QMSR knowledge

ISO 13485

CAPA and audit readiness

Technical documentation

Education

Bachelor’s degree in biomedical engineering

Tools

NetSuite

Power BI

Minitab

Excel

Job description

Rhythm Healthcare is a leading provider of DME, HME and Respiratory products in the medical equipment manufacturing industry. We exist to bring comfort, safety, independence and hope to people that connect with our brand. We are committed to ensuring that every customer feels valued and cared for.

As we continue to grow, we're committed to offering exceptional work experience for our employees with numerous opportunities for development and advancement. If you believe in our core values of Emotional Intelligence, Grit, Growth Mindset and Sincerity, we want you on our team. Our employees are our greatest asset, and this includes people like you!

JOB SUMMARY

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.

JOB DUTIES

Post-Market Product Quality and Complaint Investigations

• 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.

Technical Escalation and Customer Support

• 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.

Service Quality, Training, and Knowledge Management

• Create and maintain controlled troubleshooting guides, service bulletins, repair protocols, diagnostic methods, knowledge-based content, and technical training materials.
• D efine 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.

CAPA, Nonconformance, and Root Cause Analysis

• 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.

QMS, Audit, Change, Supplier, and Risk Support

• 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.

MINIMUM QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

• 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.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors .

The pay range for this role is:

120,000 - 125,000 USD per year (Atlanta)