PLM & Quality Systems Specialist

The role

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.

All jobs

PLM & Quality Systems Specialist

Noctrix Health, Pittsburgh, PA +1

The role

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.

What you will do

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

PLM & Quality Systems Specialist

The role

PLM & Quality Systems Specialist

The role

What you will do

What you need

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About Noctrix Health

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Noctrix Health