Quality & Regulatory Specialist (ISO 9001 / ISO 13485)

Job Description

Job Description

Quality Assurance & Regulatory Specialist

ISO 13485 | ISO 9001 | Medical Device Manufacturing

Reno, NV
Full-Time
Direct Hire Opportunity

Help Build and Maintain World-Class Quality Systems

Are you passionate about quality, compliance, and continuous improvement?

We are seeking a Quality Assurance & Regulatory Specialist to join a growing manufacturing organization operating within a highly regulated environment. This role offers the opportunity to work directly with quality leadership while supporting ISO-certified quality systems, regulatory compliance initiatives, audits, CAPA programs, and continuous improvement efforts.

This is an excellent opportunity for a quality professional looking to expand their expertise in quality management systems, regulatory compliance, medical device manufacturing, and international quality standards.

If you enjoy solving problems, improving processes, and ensuring organizations remain audit-ready and compliant, we want to hear from you.

What You'll Be Doing

Quality Management System (QMS)

• Support the maintenance and continuous improvement of the Quality Management System
• Help ensure compliance with ISO 9001 and ISO 13485 standards
• Maintain quality documentation, records, and controlled documents
• Support change control processes and document revisions

Audit & Compliance Support

• Participate in internal and external audits
• Assist with audit preparation, coordination, responses, and corrective actions
• Help maintain inspection readiness at all times
• Support compliance with FDA and international regulatory requirements

CAPA & Continuous Improvement

• Support Corrective and Preventive Action (CAPA) processes
• Track investigations, root cause analyses, corrective actions, and effectiveness checks
• Monitor quality metrics and identify opportunities for improvement
• Help drive initiatives that improve product quality and operational efficiency

Regulatory Support

• Assist with regulatory documentation and compliance activities
• Support technical file maintenance and documentation readiness
• Help ensure compliance with applicable U.S. and international regulations
• Support quality and regulatory projects as the company grows

Cross-Functional Collaboration

• Partner with Operations, Production, Engineering, Supply Chain, and Leadership teams
• Support supplier quality activities and vendor documentation reviews
• Participate in risk management and product quality initiatives
• Assist with employee quality training and training documentation

Qualifications

Required

• Bachelor's degree or equivalent experience
• 2+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance
• Working knowledge of:
  • ISO 9001
  • ISO 13485
  • CAPA Systems
  • Internal Auditing
  • Document Control
  • Quality Management Systems (QMS)
• Strong organizational and documentation skills
• Experience working in a regulated manufacturing environment
• Proficiency with Microsoft Office Suite

Preferred

• Medical Device Manufacturing experience
• IVD (In Vitro Diagnostics) experience
• FDA 21 CFR Part 820 experience
• IVDR experience
• Supplier Quality experience
• Electronic QMS experience
• Root Cause Analysis and Risk Management tools
• Internal Auditor certification

What Success Looks Like

In this role, you will help ensure:

• Quality systems remain compliant, organized, and audit-ready
• CAPAs and quality initiatives are completed effectively
• Regulatory documentation is accurate and maintained properly
• Audits are successfully completed with minimal findings
• Cross-functional teams receive strong quality and compliance support
• Continuous improvement initiatives enhance quality, efficiency, and compliance

Why Join Us?

• Stable and growing manufacturing organization
• Opportunity to work within a regulated, high-tech environment
• Exposure to both quality and regulatory functions
• Collaborative team culture
• Professional growth opportunities
• Direct impact on product quality, compliance, and company success

If you're looking for a role where your quality expertise can make a measurable impact while continuing to grow your career, we encourage you to apply today.