Quality & Regulatory Specialist

Med Mizer•Batesville, IN

4d•Hybrid

About The Position

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.

Requirements

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.
Demonstrated experience with FDA QMSR / ISO 13485.
Demonstrated experience with CAPA systems.
Demonstrated experience with Internal auditing.
Demonstrated experience with Risk management (ISO 14971 preferred).
Demonstrated experience with Supplier qualification and supplier corrective actions.
Demonstrated experience with Validation activities (IQ/OQ/PQ).
Demonstrated experience with Complaint investigations.
Demonstrated experience with Document control and change management.
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.

Nice To Haves

ISO 14971 preferred for risk management.

Responsibilities

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.
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.
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.
Review and approve validation protocols and reports.
Support process improvement and process capability initiatives.
Ensure manufacturing changes are properly evaluated and validated.
Manage the internal audit program.
Coordinate external audits, customer audits, certification audits, and regulatory inspections.
Track audit findings through closure.
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.
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.
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.