Fusion Life Sciences Technologies LLC · 1 day ago
Quality Engineer
Fusion Life Sciences Technologies LLC is seeking a Quality Engineer to ensure that cell processes are correctly base-lined and controlled. The role involves supporting the Material Review Board for internal non-conformances, leading corrective actions, and improving quality systems to meet industry standards.
Responsibilities
Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC
Supports the Material Review Board (MRB) for internal non-conformances and customer returns
May lead or verify effectiveness of corrective and preventive actions (CAPAs)
Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements
Responsible for creating, implementing and improving quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements
Qualification
Required
CAPA, Root Cause Analysis
0-3 years' experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T
Working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulation
Preferred
Bachelor's Degree in Engineering or related field
Med device and Manufacturing experience
Company
Fusion Life Sciences Technologies LLC
Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive.