Quality & Regulatory Specialist - FDA QMSR & ISO 13485 Medical Device Manufacturing
Company Overview
Med-Mizer is a leading manufacturer of hospital beds, specialty seating, and safe patient-handling solutions. Our mission is to provide high-quality, innovative products that enhance patient care and safety. We are seeking a hands-on Quality & Regulatory Specialist who can support and continuously improve our FDA QMSR & ISO 13485 Quality Management System to support our manufacturing operations. The ideal candidate will have a strong background in manufacturing quality systems and safety regulations. This position will work closely with the QA/RA Manager and operational teams to maintain a safe, compliant, and efficient work environment while supporting quality objectives throughout the organization.
Med-Mizer, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Position: Quality & Regulatory Specialist
Schedule: Monday - Friday 6:00am - 3:00pm
Key Responsibilities
Quality Management System (QMS)
- Manage and maintain the FDA QMSR / ISO 13485 Quality Management System.
- Ensure compliance with all applicable regulatory and customer requirements.
- Oversee document control and record retention processes.
- Coordinate Management Review activities and present quality system performance metrics.
- Ensure quality objectives are established, monitored, and achieved.
- Maintain inspection readiness and audit preparedness.
CAPA and Nonconformance Management
- Lead the Corrective and Preventive Action (CAPA) program.
- Ensure timely investigation and closure of quality issues.
- Facilitate root cause investigations.
- Monitor effectiveness of corrective actions.
- Manage nonconforming product processes and disposition activities.
Risk Management
- Ensure risk management activities comply with ISO 14971 requirements.
- Participate in risk assessments associated with products, processes, equipment, and suppliers.
- Support implementation of risk controls and verification of effectiveness.
- Ensure risk management files remain current and complete.
Validation and Quality Engineering Support
- Review and approve validation protocols and reports.
- Support process improvement and process capability initiatives.
- Ensure manufacturing changes are properly evaluated and validated.
Internal Audits and Regulatory Inspections
- Manage the internal audit program.
- Coordinate external audits, customer audits, certification audits, and regulatory inspections.
- Track audit findings through closure.
Supplier Quality Management
- Ensure supplier qualifications and monitoring programs meet ISO 13485 requirements.
- Manage supplier audits and supplier performance reviews.
- Oversee supplier corrective action requests (SCARs).
- Support supplier risk assessments and change management.
Customer Quality and Complaint Handling
- Manage customer complaint investigations.
- Ensure complaint-handling processes meet applicable regulatory requirements.
- Analyze customer quality trends and implement improvement actions.
- Serve as primary escalation point for customer quality issues.
Training and Quality Culture
- Ensure employee training programs meet regulatory and quality requirements.
- Verify personnel competency for quality-critical tasks.
- Promote quality awareness throughout the organization.
- Support continuous improvement initiatives across all departments.
Success Measures
- Successful maintenance of ISO 13485 implementation
- Timely closure and effectiveness of CAPAs
- Reduction in customer complaints and internal quality issues
- Successful completion of internal, customer, and certification audits
- Supplier quality performance improvements
- On-time completion of Management Reviews and Quality Objectives
Qualifications
Preferred Background
- Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related field.
- 3+ years of progressive quality experience in a regulated manufacturing environment.
- 3+ years working with ISO 13485 Quality Management Systems.
- Experience leading internal, customer, and certification audits.
- Strong knowledge of CAPA, nonconformance management, change control, complaint handling, and supplier quality.
- Experience in FDA-regulated medical device manufacturing is highly preferred.
Technical Expertise: demonstrated experience with:
- FDA QMSR / ISO 13485
- CAPA systems
- Internal auditing
- Risk management (ISO 14971 preferred)
- Supplier qualification and supplier corrective actions
- Validation activities (IQ/OQ/PQ)
- Complaint investigations
- Document control and change management
Physical Requirements
- Primarily office-based with time spent in manufacturing environments.
- Ability to walk production floors as needed to support quality and regulatory systems.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Compensation & Benefits
- Competitive salary (exempt position)
- Annual bonus program
- Three weeks of paid vacation
- Ten paid holidays per year
- Health, Dental, Vision, and Life Insurance (immediate eligibility)
- Health Savings Account (HSA) option
- 401(k) retirement plan options
- Family owned and growing company environment