PLM & Quality Systems Specialist

The role

This person will own Product Lifecycle Management and document control processes. They will serve as a subject-matter expert for PLM and eQMS processes to support product development, change management, and design transfer.

What you will do

• Own and improve Product Lifecycle Management and document-control processes
• Serve as the PLM/eQMS subject-matter expert
• Develop and maintain QMS documentation including DHF, BOMs, SOPs, forms, and templates
• Manage document version control, review, approval, release, and archival
• Administer DCO and ECO processes
• Configure and tailor PLM/eQMS workflows and system functionality
• Support NPI, design transfer, product changes, and sustaining engineering
• Maintain traceability across requirements, design outputs, BOMs, and risk management
• Manage BOM configuration and product data
• Support internal and external audits

Required qualifications

• 5+ years of relevant experience within an FDA- and/or ISO-regulated environment
• Demonstrated ownership of document control, PLM, configuration management, or quality-system processes
• Hands-on experience administering and working within PLM or eQMS platforms such as Arena or equivalent systems
• Demonstrated experience configuring and tailoring PLM/eQMS workflows, document structures, approval processes, and change-control workflows
• Experience administering DCO and ECO processes within a regulated product-development environment
• Strong understanding of document control, version control, configuration management, and controlled product release processes
• Experience supporting NPI, design transfer, product changes, and sustaining engineering activities
• Experience managing BOMs, product configuration data, and associated product documentation
• Working knowledge of ISO 13485, 21 CFR Part 820, and 21 CFR Part 11
• Demonstrated experience identifying process inefficiencies and implementing scalable improvements
• Strong documentation skills and proficiency with Microsoft Excel, Word, and PowerPoint
• Strong analytical and problem-solving skills

Nice to have

• Medical device industry experience, particularly with Class II devices
• Experience supporting Design History Files and other design-control documentation
• Experience with Arena PLM/eQMS
• Experience with BOM management, configuration control, supplier information, and product costing
• Experience establishing PLM/eQMS dashboards, metrics, and change-control performance reporting
• Experience supporting internal audits, external audits, or regulatory inspections
• Experience improving document-control or change-management processes within a high-growth organization
• Experience using automation or AI tools to improve process efficiency or data quality
• Experience working within a startup, growth-stage, or rapidly evolving medical device organization

About the company

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. The team consists of medical device specialists, neuroscientists, and consumer electronics engineers.