Senior Quality Engineer

About Rhythm Healthcare LLC

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.

To learn more about us, visit our website at www.rhythmhc.com.

JOB SUMMARY

The Quality Engineer (QE) / Senior Quality Engineer (Sr. QE) supports and improves the Quality Management System (QMS) while ensuring compliance with FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, MDSAP, and applicable global regulatory requirements. This role partners with Operations, Engineering, Regulatory Affairs, Supply Chain, and Customer Service to support safe, effective, and compliant medical device manufacturing and distribution.

The ideal candidate is a hands-on quality professional with experience in quality systems, CAPA, complaints, change control, nonconforming product, supplier quality, audits, and process improvement, supported by strong analytical, technical writing, and cross-functional leadership skills.

ESSENTIAL JOB FUNCTIONS

• Quality Management System

• Maintain the QMS in accordance with FDA 21 CFR Part 820/QMSR, ISO 13485, MDSAP, and applicable regulatory requirements.
• Ensure quality records are complete, accurate, inspection ready, and aligned with Management Review metrics and reporting.
• Develop and revise quality procedures, work instructions, forms, and records.

• CAPA, Complaints, and Nonconforming Product

• Lead CAPA investigations, root cause analysis, implementation verification, effectiveness checks, aging/closure tracking, and trend reporting.
• Investigate complaints and nonconforming product, support disposition decisions, determine escalation needs, and collaborate with Customer Service, Regulatory Affairs, and Operations.

• Change Control and Supplier Quality

• Review ECOs and change requests, evaluate quality/regulatory impact, support CRB meetings, and ensure changes are documented, implemented, and verified.
• Support supplier qualification, audits, performance reviews, SCARs, and resolution of supplier quality issues with Purchasing and Operations.

• Audits, Risk Management, and Validation

• Support internal, supplier, FDA, ISO 13485, MDSAP, and customer audits; prepare objective evidence; respond to findings; and verify corrective actions.
• Support ISO 14971 risk management, FMEA activities, quality risk evaluations, equipment qualification, process/software/test method validation, and manufacturing process improvements.
• Support Regulatory market clearance activities, technical file reviews, compliance gap assessments and remediation plans.

• Data Analysis, Improvement, and Collaboration

• Develop Quality KPIs/dashboards; analyze trends for complaints, CAPAs, nonconforming product, suppliers, and audits; and recommend Lean/Six Sigma improvements.
• Partner cross-functionally with Engineering, Regulatory Affairs, Manufacturing, Operations, Purchasing, Customer Service, Distribution, and Executive Leadership.

Education & Experience

• Education:

• Bachelor’s degree in Biomedical, Mechanical, Industrial, Chemical, Manufacturing Engineering, Life Sciences, or a related technical discipline.

• Quality Engineer:

• 3–5 years of Quality Engineering experience in a regulated medical device environment.

• Senior Quality Engineer:

• 5–8+ years of progressive medical device quality engineering experience, including quality improvement leadership and cross-functional initiatives.

• Regulatory/QMS Knowledge:

• FDA 21 CFR Part 820/QMSR, ISO 13485, MDSAP, ISO 14971, CAPA, complaint handling, internal auditing, supplier quality, change control, nonconforming product, RCA, risk management, SPC, and document control.

• Technical Tools:

• Preferred experience with eQMS, ERP, Microsoft Office, advanced Excel, Power BI, Minitab, SharePoint, and electronic document management systems.

• Professional Skills:

• Strong technical writing, organization, attention to detail, analytical thinking, problem-solving, project management, prioritization, communication, collaboration, and ability to influence cross-functional teams.

• Preferred Certifications:

• ASQ CQE, ASQ CQA, Six Sigma Green/Black Belt, or Certified Biomedical Auditor (CBA).

Physical Requirements

• Must be able to travel as required.

• Continually utilize visual acuity to use the keyboard and read technical information.

• Frequently required to lift/push/carry items up to fifty pounds.

WHAT WE OFFER

• Competitive salary and performance-based incentives.
• Opportunities for professional growth and development.
• A collaborative and supportive work environment
• Comprehensive benefits package with UNLIMITED PTO

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.

PAY RANGE

85,000 - 105,000 USD per year (Remote)

Operations

Remote (United States)