PLM & Quality Systems Leader (Medical Devices)

Noctrix Health, Inc.; Pittsburgh (Allegheny County); Hybrid; USD 100,000 - 150,000; Full time

Job summary

Noctrix Health, Inc. seeks a detail‑oriented PLM & Quality Systems Specialist to own Product Lifecycle Management and document control across the product organization.

The role focuses on PLM/eQMS systems within FDA and ISO-regulated environments, driving efficiency, traceability, and compliant product development and change control. You will work cross‑functionally with Engineering, Quality, Regulatory, Operations, Supply Chain, and Finance to improve data accuracy, configuration control, and

Qualifications

• 5+ years in FDA/ISO-regulated environment with document control/PLM.
• Bachelor’s in Engineering preferred; PLM/eQMS experience may replace degree.
• Hands-on PLM/eQMS administration in Arena or similar.
• Experience configuring PLM/workflows and change-control processes.
• Experience with DCO/ECO in regulated setting.
• Strong docs, Excel, Word, PowerPoint.
• Detail-oriented, data integrity, traceability.
• Ability to manage multiple priorities independently.

Responsibilities

• Own PLM/eQMS workflows and document control processes.
• Support system administration, configuration, and user adoption.
• Develop and maintain DHF, BOMs, SOPs, templates.
• Ensure records are controlled and compliant with regs.
• Manage document version control and approvals.
• Administer DCO and ECO processes.
• Tailor PLM/eQMS workflows for Noctrix needs.
• Streamline DCO/ECO routing and reduce approvals.
• Support NPI, design transfer, sustaining activities.
• Maintain end-to-end traceability across requirements to releases.
• Manage BOM configuration and costing data.
• Collaborate across functions to improve data visibility.
• Track open changes, releases, aging, bottlenecks.
• Develop metrics/dashboards for document-control performance.
• Identify inefficiencies and implement scalable improvements.
• Leverage automation/AI to improve workflows.
• Develop long-term PLM/eQMS roadmap.
• Support audits and ensure docs are accessible.
• Provide training on PLM/eQMS processes.
• Maintain ownership and manage priorities in regulated env.

Skills

PLM expertise

eQMS admin

Regulatory knowledge

Document control

Cross-functional

BOM management

Process improvement

Education

Bachelor's in Engineering

Tools

Arena PLM

Job description

Noctrix Health, Inc. seeks a detail‑oriented PLM & Quality Systems Specialist to own Product Lifecycle Management and document control across the product organization.

The role focuses on PLM/eQMS systems within FDA and ISO-regulated environments, driving efficiency, traceability, and compliant product development and change control. You will work cross‑functionally with Engineering, Quality, Regulatory, Operations, Supply Chain, and Finance to improve data accuracy, configuration control, and