PLM & Quality Systems Specialist (Medical Devices)

Location: Hybrid position based in the Oakmont, Pennsylvania office, with a minimum of three days onsite per week or more depending on business needs.

Company

hirify.global develops clinically validated therapeutic wearables and prescription-grade, drug-free treatments for chronic neurological disorders, including drug-resistant Restless Legs Syndrome.

What you will do

• Own and continuously improve PLM, eQMS, product document-control, configuration-management, and change-control processes.
• Administer and configure PLM/eQMS workflows, approval structures, document architectures, templates, and system functionality.
• Maintain controlled product records, including DHFs, BOMs, SOPs, forms, design outputs, risk-management documentation, verification and validation records, manufacturing documentation, and released product records.
• Manage document version control, review, approval, release, archival, DCO/ECO processing, NPI, design transfer, product changes, and sustaining engineering support.
• Improve BOM, supplier, sourcing, and costing data in collaboration with Engineering, Operations, Supply Chain, Finance, Quality, Regulatory, and Program Management.
• Develop metrics, dashboards, improvement roadmaps, training, audit support, and controlled automation or AI-enabled workflows.

Requirements

• 5+ years of relevant experience in an FDA- and/or ISO-regulated environment, including 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 substitute for the degree.
• Hands-on administration and use of PLM or eQMS platforms such as Arena or equivalent, including configuration of workflows, document structures, approval processes, and change-control workflows.
• Experience administering DCO and ECO processes in a regulated product-development environment.
• Strong understanding of document control, version control, configuration management, controlled product release, data integrity, traceability, and documentation accuracy.
• Experience supporting NPI, design transfer, product changes, sustaining engineering, BOMs, product configuration data, and related product documentation.
• Working knowledge of medical-device quality and regulatory requirements, including ISO 13485, 21 CFR Part 820, and 21 CFR Part 11.
• 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, problem-solving, communication, and cross-functional collaboration skills.
• Ability to work independently, manage multiple priorities, and adapt to changing business needs.

Nice to have

• Medical-device industry experience, particularly with Class II devices.
• Experience with Design History Files, Arena PLM/eQMS, 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 in a high-growth organization.
• Experience using automation or AI tools to improve process efficiency or data quality within a controlled environment.
• Experience in a startup, growth-stage, or rapidly evolving medical-device organization.

Culture & Benefits

• Full-time hybrid work based in the Oakmont, Pennsylvania office.
• At least three onsite days per week, with additional onsite work depending on business needs.
• Cross-functional work across Product, Engineering, Quality, Regulatory, Operations, Supply Chain, Finance, and Program Management.
• Work within a dynamic, regulated product-development environment with responsibility for scalable, traceable, and compliant systems.