PLM & Quality Systems Specialist

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 mechanisms for tracking open document changes, upcoming releases, aging changes, bottlenecks, and overdue approvals

Develop and maintain metrics and dashboards for document-control performance, change-order cycle time, approval aging, compliance, and overall process effectiveness

Identify inefficiencies within PLM, document-control, and quality-system processes and implement scalable improvements that increase efficiency, traceability, and usability

Evaluate and appropriately leverage automation and AI tools to improve process efficiency, data quality, and administrative workflows within a controlled environment

Develop and maintain a prioritized roadmap for longer-term PLM/eQMS improvements, automation, and system optimization

Support internal and external audits by ensuring Product documentation is complete, controlled, traceable, and readily accessible

Support audit and inspection requests related to product records, design documentation, change control, and PLM/eQMS processes

Provide guidance and training to Product and cross-functional users on PLM/eQMS processes, document-control requirements, and system best practices

Maintain a high level of ownership and independence while managing multiple priorities within a dynamic, regulated product-development environment

Requirements

5+ years of relevant experience within an FDA- and/or ISO-regulated environment, including demonstrated ownership of document control, PLM, configuration management, or quality-system processes

Bachelor’s degree in Engineering or a related technical field preferred; relevant PLM/eQMS and regulated-industry experience may be considered in lieu of a degree

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 applicable medical device quality and regulatory requirements, including ISO 13485, 21 CFR Part 820, and 21 CFR Part 11

Demonstrated experience identifying process inefficiencies and implementing scalable PLM, document-control, or quality-system improvements

Strong documentation skills and proficiency with Microsoft Excel, Word, and PowerPoint

Strong analytical and problem-solving skills with the ability to identify workflow bottlenecks and develop practical solutions

Strong attention to detail and commitment to data integrity, traceability, and documentation accuracy

Ability to work independently, manage multiple priorities, and adapt to changing business needs

Strong interpersonal and communication skills with the ability to collaborate effectively across Engineering, Quality, Regulatory, Operations, Supply Chain, Finance, and Program Management

Preferred Qualifications

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 within an appropriately controlled environment

Experience working within a startup, growth-stage, or rapidly evolving medical device organization