MedTech Supply Chain Prod Planner (Contract) – 1st Shift

Millenniumsoft; San Jose (CA); Presencial; USD 28.000 - 34.000; Tempo integral

Resumo da vaga

Millenniumsoft is seeking a Supply Chain Production Planner for a 9+ month contract in San Jose, CA. The role requires coordination with manufacturing to ensure readiness during product phase in/out, and managing documentation within SAP and Documentum for IVDR compliance.

The candidate should have a biology background, experience in regulated manufacturing, and strong documentation and communication skills to support regulatory submissions and data loads.

Qualificações

• Requires a Bachelor’s degree in biological sciences and 1 year of experience in a manufacturing or laboratory environment.
• Prior experience in a FDA or ISO medical device regulated manufacturing environment desirable.
• Knowledge of GMPs and regulatory requirements.

Responsabilidades

• Create and update manufacturing documents (Specifications and procedures) and master data (BOMs and routings) impacted by the IVDR program; prepare and submit ACRs and ECRs.
• Coordinate with Planning and Manufacturing to ensure readiness for phase out of old versions and phase in of new versions of products with labeling and packaging changes.
• Review documents in Documentum, SAP and other archives to gather and summarize data to support regulatory submissions.
• Provide data for PIM/ EuDaMed data load and ongoing maintenance.
• Assist in tasks to support IVDR and Reagent Operations.

Conhecimentos

Documentation

Communication

Organization

Formação

Bachelor’s degree in biological sciences

Ferramentas

SAP

Documentum

Descrição da vaga

Millenniumsoft is seeking a Supply Chain Production Planner for a 9+ month contract in San Jose, CA. The role requires coordination with manufacturing to ensure readiness during product phase in/out, and managing documentation within SAP and Documentum for IVDR compliance.

The candidate should have a biology background, experience in regulated manufacturing, and strong documentation and communication skills to support regulatory submissions and data loads.