Product Data Management (PDM) and Engineering Change processes for regulated pathology and medical equipment. Ensures compliant master data, documentation, and change implementation across the product lifecycle within ERP and PLM systems, in alignment with Quality Management System (QMS) and regulatory requirements..
Responsibilities
- role is documentation, governance, and global standardization of Pathology, Reagent Partner, and CDx master data, ensuring compliant creation, maintenance, and communication of regulated product attributes across Agile PLM, SAP, and POMS, in alignment with QMS, change control, and medical device regulatory requirements throughout the product lifecycle.
- Person would be required to Implement, manage, and sustain the Engineering Change Management (ECN/ECO) process, including master data and document control across the complete product lifecycle within PLM and ERP systems (Agile & SAP). Lead and coordinate Engineering Change Orders (ECOs) for the release and maintenance of sales and production Bills of Materials (BOMs).
Core Areas:
- [Medical Device / Regulated Product Change Management
- Engineering Change Control (ECO/ECN)
- QMS, GMP, GLP, GCP Compliance
- PLM (Agile) & ERP (SAP) Master Data Management
- Cross‑functional Coordination & Stakeholder Management
- Documentation Control & Audit Readiness
Qualifications
Graduation/Post Graduation having relevant experience on medical equipment's / pathology
