Senior Quality Engineer

Rhythm Healthcare

8d•$85,000 - $105,000

About The Position

Rhythm Healthcare is a leading provider of DME, HME and Respiratory products in the medical equipment manufacturing and distribution 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! Apply today and join the Rhythm family. To learn more about us, visit our website at www.rhythmhc.com. 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.

Requirements

Bachelor’s degree in Biomedical, Mechanical, Industrial, Chemical, Manufacturing Engineering, Life Sciences, or a related technical discipline.
5–8+ years of progressive medical device quality engineering experience, including quality improvement leadership and cross-functional initiatives.
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.
Strong technical writing, organization, attention to detail, analytical thinking, problem-solving, project management, prioritization, communication, collaboration, and ability to influence cross-functional teams.

Nice To Haves

Experience with eQMS, ERP, Microsoft Office, advanced Excel, Power BI, Minitab, SharePoint, and electronic document management systems.
ASQ CQE, ASQ CQA, Six Sigma Green/Black Belt, or Certified Biomedical Auditor (CBA).

Responsibilities

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.
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.
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.
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.
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.