Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health.
We are seeking an experienced and detail-oriented PLM & Quality Systems Specialist to own Product Lifecycle Management (PLM) and document control processes supporting Noctrix Health’s Product organization. This role will serve as a key subject-matter expert for PLM and eQMS processes, helping ensure the systems and workflows supporting product development, change management, design transfer, and sustaining activities are efficient, scalable, traceable, and compliant.
The ideal candidate brings hands-on experience administering PLM or eQMS platforms within an FDA- and ISO-regulated environment and is comfortable managing day-to-day document and change-control activities while also identifying and implementing process improvements. This individual will work cross-functionally with Engineering, Quality, Regulatory, Operations, Supply Chain, Finance, and Program Management to improve product data accuracy, configuration control, process efficiency, and quality-system usability.
This is a full-time, hybrid position based in our office in Oakmont, PA, with a minimum of three days onsite per week, or more depending on business needs.
Responsibilities
Own and continuously improve Product Lifecycle Management and Product document-control processes, including workflows, templates, approval structures, configuration management, and change control
Serve as the Product team’s PLM/eQMS subject-matter expert, supporting system administration, workflow configuration, troubleshooting, user adoption, and continuous improvement
Develop, maintain, and improve QMS documentation supporting Product activities, including Design History Files (DHF), Bills of Materials (BOMs), SOPs, forms, templates, and related product records
Ensure product records are accurate, complete, appropriately controlled, and maintained in accordance with company procedures and applicable regulatory requirements
Manage document version control, review, approval, release, implementation, and archival activities
Administer Document Change Order (DCO) and Engineering Change Order (ECO) processes, ensuring changes are appropriately documented, reviewed, approved, and implemented
Configure and tailor PLM/eQMS workflows, document structures, approval processes, and system functionality to support Noctrix-specific product development and quality-system needs
Evaluate DCO/ECO workflows and identify opportunities to simplify routing, reduce unnecessary approvals, improve cycle time, and strengthen compliance
Support New Product Introduction (NPI), design transfer, product changes, and sustaining engineering activities through effective document release and configuration management
Maintain end-to-end traceability and configuration control across requirements, design outputs, BOMs, risk management documentation, verification and validation records, change management, manufacturing documentation, and released product records
Manage BOM configuration and product data to ensure clear and accurate communication of component, supplier, sourcing, and costing information
Partner with Engineering, Operations, Supply Chain, and Finance to improve the accuracy, visibility, and usability of supplier and cost information within product BOMs
Collaborate with Quality and Regulatory teams to ensure Product documentation and PLM processes align with QMS requirements and applicable regulatory expectations
Establish and maintain…