Medical Device Quality & Technical Support Manager

Rhythm Healthcare; United States; On-site; USD 120,000 - 125,000; Full time

Job summary

Rhythm Healthcare is seeking a Technical Support Manager to lead quality engineering across field performance, complaint investigations, CAPA, and post-market improvements for our respiratory and DME products.

You will partner with Regulatory Affairs, Operations, and Product Management to translate field feedback into risk-based product/service enhancements andQMS enhancements. Experience in medical devices and FDA/ISO quality systems is required.

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; experience with NetSuite, Power BI, Minitab, or advanced Excel preferred.

Responsibilities

• 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 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 risk management, equipment and test qualification, and quality aspects of new product/service readiness.

Skills

Quality engineering

Root cause analysis

Regulatory compliance

Troubleshooting

Education

Bachelor’s degree in biomedical engineering

ISO 13485 knowledge

Tools

eQMS

Power BI

Minitab

NetSuite

Job description

Rhythm Healthcare is seeking a Technical Support Manager to lead quality engineering across field performance, complaint investigations, CAPA, and post-market improvements for our respiratory and DME products.

You will partner with Regulatory Affairs, Operations, and Product Management to translate field feedback into risk-based product/service enhancements andQMS enhancements. Experience in medical devices and FDA/ISO quality systems is required.