Quality & Regulatory Specialist

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

• Bachelors 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