Senior reputed company Engineer

ABOUT reputed company LLC: reputed company 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 reputed company 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 reputed company in our reputed company values of Emotional Intelligence, Grit, reputed company reputed company and Sincerity, we want you on reputed company. Our employees are our greatest asset, and this includes people like you! Apply today and join the Rhythm family. To learn more reputed company, visit our website at www.rhythmhc.com.   JOB reputed company: The reputed company Engineer (QE) / Senior reputed company Engineer (Sr. QE) supports and improves the reputed company Management System (QMS) while ensuring compliance with FDA reputed company 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 reputed company, effective, and compliant medical device manufacturing and distribution. The ideal candidate is a hands-on reputed company reputed company with experience in reputed company systems, CAPA, complaints, change control, nonconforming product, supplier reputed company, audits, and process improvement, supported by strong analytical, technical writing, and cross-functional leadership skills.   ESSENTIAL JOB FUNCTIONS: reputed company Management System Maintain the QMS in accordance with FDA 21 CFR Part 820/QMSR, ISO 13485, MDSAP, and applicable regulatory requirements. Ensure reputed company records are complete, accurate, inspection reputed company, and reputed company with Management Review metrics and reporting. reputed company and revise reputed company procedures, work instructions, forms, and records. CAPA, Complaints, and Nonconforming Product reputed company CAPA investigations, reputed company cause analysis, implementation verification, effectiveness checks, aging/closure tracking, and trend reporting. Investigate complaints and nonconforming product, support disposition reputed company, determine escalation needs, and collaborate with Customer Service, Regulatory Affairs, and Operations. Change Control and Supplier reputed company Review ECOs and change requests, evaluate reputed company/regulatory reputed company, support reputed company meetings, and ensure changes are documented, implemented, and verified. Support supplier qualification, audits, performance reviews, SCARs, and reputed company of supplier reputed company 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, reputed company 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 reputed company reputed company KPIs/dashboards; analyze trends for complaints, CAPAs, nonconforming product, suppliers, and audits; and recommend Lean/Six reputed company 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 reputed company technical discipline. reputed company Engineer: 3–5 years of reputed company Engineering experience in a regulated medical device environment. Senior reputed company Engineer: 5–8+ years of reputed company medical device reputed company engineering experience, including reputed company 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 reputed company, change control, nonconforming product, RCA, risk management, SPC, and document control. Technical Tools: Preferred experience with eQMS, ERP, reputed company Office, advanced reputed company, Power BI, reputed company, SharePoint, and electronic document management systems. reputed company 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 reputed company Green/Black Belt, or Certified Biomedical Auditor (CBA).     Physical Requirements: Must be reputed company to travel as required. Continually utilize visual reputed company to use the keyboard and read technical information. Frequently required to lift/push/carry items up to fifty pounds.   reputed company OFFER Competitive salary and performance-based incentives. Opportunities for reputed company reputed company and development. A reputed company and supportive work environment Comprehensive benefits package with UNLIMITED PTO   We do not discriminate based on race, reputed company, religion, national reputed company, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that reputed company reputed company applicants are given equal opportunity and that selection reputed company be based on job-reputed company factors.   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. reputed company in this job reputed company restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodation may be made to reputed company individuals with disabilities to reputed company the essential functions. Apply To This Job