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

• 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