Knowledge of ISO and FDA regulations related to quality systems and design transfer.
Previous experience in the medical device industry is required.
Minimum of 5 years in medical device manufacturing.
Experience with process control and documentation management.
Familiarity with risk management tools such as PFMEA.
Responsibilities
Support manufacturing process improvements for new product launches.
Assist in scheduling and tracking design transfer deliverables.
Initiate changes to manufacturing documentation for processes and inspections.
Update risk management documentation including PFMEA.
Create parts within the Windchill system and manage BOMs.
Collaborate with cross-functional teams including R&D, Quality, and Regulatory.
Ensure compliance with FDA regulations and maintain positive communication with stakeholders.
Benefits
Opportunity to work on cutting-edge medical device products.
Cross-functional collaboration leading to professional growth.
Engagement with compliance and regulatory environments in a pivotal industry.
Full Job Description
Roles & Responsibilities:
Support in Manufacturing process remediation and readiness activities for new product launch.
Support Design Transfer deliverables, including tracking and scheduling.
Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.
Risk Management updates - PFMEA.
Part creation in Windchill. BOM and configuration management.
Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements:
Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
Previous medical device experience
5+ years of Medical device Manufacturing experience
