Quality Manager - Biomedical Search Consultants

Our client, a company servicing global healthcare and medical device companies, has an immediate opening for a Quality Manager. This role is responsible for the implementation of new customer processes, including design and development of production fixtures and workflow documentation.Responsibilities:

• Perform Inspection Supervisor area duties
• Implement new customer processes including process transfer from development to production
• Assess customer specifications, drawings, and change orders for proper implementation
• Evaluate, define, and implement internal process changes and enhancements
• Drive new projects to completion through robust project management including management of internal and external resources
• Create, review, and refine process validation documents including IQ’s, OQ’s, and PQ’s
• Create, review, and edit process flow maps and p-FMEA documents
• Create, review, and improve training instructions
• Collect data and provide data analysis, interpretation, and trending derived from the Inspection Access database or other data sources, including tracking of management defined KPI’s
• Evaluate proposed trials and production jobs for the company’s ability to implement them, and provide quantitative assessments of resource requirements, including labor, materials, and equipment, for input into financial cost estimate models
• Maintain staff by recruiting, selecting, orienting, and training employees
• Other responsibilities as required

Requirements:

• Bachelor’s degree in Manufacturing, Industrial, Electrical, or Mechanical Engineering
• 3+ years in a leadership position
• 5+ years of hands-on professional experience in a medical device manufacturing environment
• Experience in a regulated environment such as medical devices
• A collaborative mindset, a flexible and friendly approach to working in teams
• Familiarity of LEAN principles preferred