Process Optimization Specialist

3 weeks ago


Buford, Georgia, United States Theragenics Full time

Job Title: Process Optimization Specialist

About Us: At Theragenics, we strive to integrate manufacturing processes with quality management systems, driving operational efficiency and product excellence.

About the Role:

  • We are seeking a talented Process Optimization Specialist to develop, implement, and maintain quality management systems (QMS) to support continuous improvement across product lines and processes.
  • You will conduct root cause analysis (RCA) for non-conformances, corrective actions (CAPAs), and audit findings, ensuring compliance with industry standards (e.g., ISO 13485, FDA 21 CFR Part 820, MDR).
  • This role involves collaborating with cross-functional teams to resolve quality issues and ensure timely implementation of preventive measures, including statistical process control (SPC), process capability studies (Cp/Cpk), and gage R&R.
  • You will oversee product inspection and testing activities, establish and monitor key performance indicators (KPIs) related to product quality and process effectiveness, and assume an active role in the selection and certification of strategic suppliers.
  • In this position, you will have the opportunity to participate in evaluation of current processes and develop options for changes to ensure continuous efficient operations in manufacturing.

Requirements:

  • Bachelor's degree in engineering, Life Sciences, or a related technical field is required; advanced degree or equivalent experience is preferred.
  • A minimum of 1-3 years of experience in process or quality engineering, preferably within the medical device industry, is necessary.

Salary: $75,000 - $95,000 per year



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