Job Summary:
The role of Quality Engineer involves collaborating with various departments to ensure the implementation of quality plans, programs, and procedures. This includes utilizing quality control statistics, lean manufacturing concepts, and analysis to guarantee that performance and product quality meet established company, customer, and regulatory requirements.
To achieve this, the Quality Engineer will assist in reviewing, analyzing, and reporting on quality discrepancies related to assembly and process. Additionally, they will investigate problems and recommend disposition, modification, and corrective action for recurring or non-recurring discrepancies.
The ideal candidate will have experience in sterilization, automation, equipment/software validation, and manufacturing within controlled environments. They should also be familiar with FDA, QSR, & MDD standards and possess a root cause problem-solving approach in a team environment.
Key Responsibilities:
* Develop and implement quality plans, programs, and procedures
* Assist in reviewing, analyzing, and reporting on quality discrepancies
* Investigate problems and recommend corrective action
* Interface with manufacturing, engineering, customer, vendor, and subcontractor representatives
* Provide technical support during the NPI process
Required Skills and Qualifications:
* Bachelor's degree in Engineering or Science or similar discipline
* At least 3 to 5 years' experience in a Quality Engineering role
* Fully competent in Quality Management Standards
* Excellent leadership skills, ability to motivate team members
* Excellent organization, communication, computer, and presentation skills
* Excellent initiative, decision-making, and ability to work in a core team environment
About the Role:
This is an exciting opportunity for a skilled Quality Engineer to join our team and contribute to ensuring the delivery of high-quality products while maintaining compliance with regulatory requirements.