Director of Manufacturing and Supply Chain – InGeneron

The Director of Manufacturing and Supply Chain directs the organization’s overall manufacturing and supply chain operations from purchasing through production through final distribution of goods including transition of new products into the manufacturing system. They work closely with the company’s Quality Team.

Key Responsibilities include but are not limited to:

  • Manage production and assembly activities in compliance with company policy and Standard Operating Procedures (SOPs)
  • Oversee employees and training for production and facility related processes
  • Evaluates past performance data to forecast inventory needs and production scheduling to support customers’ needs
  • Responsible for maintaining InGeneron MRP/ERP systems
  • Facilitate and supervise new R&D project transition to manufacturing processes.
  • Analyzes current processes and performance data to improve capability, productivity, quality, efficiency, and cost
  • Ensures production performance and quality goals are met. Reports these metrics to management
  • Identify and evaluate distribution partners
  • Manages critical and key suppliers, including coordination of quality and supply agreements, working closely with Quality Department
  • Establish systems for installation and servicing
  • Ensures a healthy and safe working environment, in compliance with federal and state regulations
  • Performs other related duties as assigned.

Involved in cGMP activities and therefore is responsible for:

  • Qualification and recertification of new and current suppliers
  • Creation and maintenance of manufacturing records
  • Create and manage manufacturing SOPs, work instructions, and employee training related to manufacturing

Qualifications and Skills:

  • Masters or bachelor’s in engineering, and 3-5 years of experience in the field or in a related area
  • 3-5 years’ experience in a CGMP environment
  • Working knowledge of applicable sections of: FDA 21 CFR820, ISO 13485, current EU Device manufacturing and supplier qualification requirements, and 21 CFR Part 11
  • Ability to multi-task, prioritize project goals, and meet client demands
  • Ability to delegate responsibility when needed
  • Working knowledge of medical device regulations

Working Conditions/Physical Requirements:

  • Position may require the use of hazardous chemicals and materials, including human tissue and body fluids, such as blood. Handling of human specimens may result in possible blood borne pathogen exposure. Appropriate safety training and equipment will be provided by the Company
  • Must be able to stand for up to 1 hour at a time
  • Lift up to 35 lbs
  • Must be able to manipulate and assemble small parts
  • Must be able to travel for supplier qualification at both domestic and international sites

Job Type: Full-time

Job Location: Houston, TX