PLM & Quality Systems Specialist

Noctrix Health•Pittsburgh, PA

6d•Hybrid

About The Position

Noctrix Health is seeking an experienced, detail-oriented PLM & Quality Systems Specialist to own Product Lifecycle Management (PLM) and document-control processes supporting the Product organization. This subject-matter expert will administer and improve PLM/eQMS processes and systems for product development, change management, design transfer, and sustaining activities, ensuring they are efficient, scalable, traceable, and compliant. The role combines day-to-day document and change-control work with system administration, workflow configuration, user support, and process improvement. The specialist will partner with Engineering, Quality, Regulatory, Operations, Supply Chain, Finance, and Program Management to improve product-data accuracy, configuration control, process efficiency, and quality-system usability. The position is full-time and hybrid, based in the Oakmont, Pennsylvania office, with at least three days onsite each week or more depending on business needs.

Requirements

At least 5 years of relevant experience in 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.
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, including 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 and ability to collaborate effectively across Engineering, Quality, Regulatory, Operations, Supply Chain, Finance, and Program Management.

Nice To Haves

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.

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 for Product activities, including Design History Files (DHF), Bills of Materials (BOMs), SOPs, forms, templates, and related product records.
Ensure product records are accurate, complete, 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 documented, reviewed, approved, and implemented appropriately.
Configure and tailor PLM/eQMS workflows, document structures, approval processes, and system functionality to support 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 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, ensuring 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 align Product documentation and PLM processes with QMS requirements and applicable regulatory expectations.
Establish and maintain mechanisms to track 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 in PLM, document-control, and quality-system processes and implement scalable improvements to 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.
Manage multiple priorities independently within a dynamic, regulated product-development environment.