Quality Engineer

POSITION SUMMARY

Utilizes engineering methodologies and other analytics to initiate, implement, and manage the quality management system that encompasses both products and processes within the facility. In addition, this position pursues improved operational effectiveness through the refinement of existing procedures or business processes to optimize validations, manufacturing processes, error proofing, and other quality system tools.

 ESSENTIAL JOB FUNCTIONS:

1. Rigorous oversight of manufacturing processes to ensure all products are made with the highest possible quality within a lean manufacturing environment.
2. Provides key oversight to root cause analysis and effective CAPAs by both leading and ensuring appropriate training throughout the facility.
3. Conducts sterilization validations in accordance with internal protocols and external standards. Supports activities related to the master sterilization plan.
4. Leverages various software programs such as Word, Excel, ERP system, Minitab and other necessary programs or project tools to manage and analyze data and complete work.
5. Provides analysis and interpretation of report data to other departments for data driven decision making.
6. May provide input to improve the Master Validation Plan by influence input of protocols that involve proper sampling techniques, design of experiments, testing and statistical rationale.
7. Innovates and develops studies for packaging which may include overseeing testing, review of data analysis and documentation results.

SUPPLEMENTAL JOB FUNCTIONS:

1. Performs additional duties as directed.