Knowledge of ISO and/or FDA quality system regulations related to design transfer and process control.
Previous experience in the medical device industry.
At least 5 years of experience in medical device manufacturing.
Responsibilities
Support manufacturing process improvements and readiness for new product launches.
Assist in tracking and scheduling design transfer deliverables.
Initiate change orders for manufacturing documentation and procedures.
Update risk management processes, including PFMEAs.
Create parts and manage BOM in Windchill.
Collaborate with cross-functional teams, especially R&D, Quality, and Regulatory.
Ensure compliance with FDA regulations and maintain positive communication with all stakeholders.
Benefits
Comprehensive health and wellness programs.
Opportunities for professional development and training.
Flexible working environment.
Supportive company culture emphasizing teamwork.
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
