What are the responsibilities and job description for the SAP QM Consultant with Life Sciences / Medical Devices Domain Experience position at SumasEdge Corporation?
Title: SAP QM Business Process Owner / Functional Lead Medical Devices
Location: Raritan, NJ (HYBRID MODE 3 DAYS A WEEK)
Duration: 6 months
Job Summary
We are seeking a senior SAP QM Business Process Owner (BPO) with deep expertise in the Medical Device / Life Sciences industry to drive global quality processes, governance, and digital transformation initiatives. This role will act as the bridge between Quality Business (QA) and IT, owning the end-to-end Quality Management process landscape in SAP S/4HANA and integrated systems. The candidate will ensure regulatory compliance, process standardization, and continuous improvement across global operations.
Key Responsibilities
- Design and Implementation of SAP QM experience must.
- Own and govern end-to-end SAP Quality Management processes.
- SAP QM Incoming, In-process, and Final Inspections
- Deep understanding of Non-Conformance / Deviations and integration with third party systems.
- Hands on experience on CAPA (Corrective & Preventive Actions) to implement solutions in SAP
- Integration from SAP QM to LIMS system.
- SAP QM process knowledge in Customer Complaints & Field Quality
- Audit & Compliance processes understanding.
- Define and maintain global process templates and standards
- Drive process harmonization across regions (US, EU, APAC)
- Ensure processes align with FDA 21 CFR Part 820 , , GxP / GMP , 21 CFR Part 11