Quality Engineer II- Medical Devices

The Quality Engineer II at Jabil/Nypro Inc. is responsible for ensuring product quality and process compliance through the application of engineering principles and quality tools. This role involves supporting medical device manufacturing operations, driving continuous improvement, and maintaining robust quality systems.

What will you do?
* Develop, implement, and maintain quality control plans and procedures for new and existing products.
* Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.
* Perform statistical analysis of data to identify trends, opportunities for improvement, and validate processes.
* Participate in design reviews and provide quality input on product and process designs.
* Support supplier quality activities, including audits, qualification, and performance monitoring.
* Lead and participate in internal and external audits to ensure compliance with relevant quality standards (e.g., ISO 13485, IATF 16949).
* Collaborate with cross-functional teams including R&D, manufacturing, and supply chain to resolve quality-related problems.
* Train and mentor junior quality personnel on quality methodologies and procedures.
* Develop and implement measurement systems analysis (MSA) studies.
* Prepare and present quality performance reports to management.

How will you get here?

* Bachelor's degree in Engineering (Mechanical, Industrial, Electrical, or related field).
* 2  years of experience in a regulated Quality role within a manufacturing environment, preferably in plastics injection molding or medical device industries.
* Strong understanding of quality management systems (e.g., ISO 9001, ISO 13485, IATF 16949).
* Proficiency in statistical process control (SPC), measurement systems analysis (MSA), and other quality tools.
* Experience with root cause analysis methodologies (e.g., 8D, 5 Whys, Fishbone diagrams).

* Supplier Quality experience is a plus.
* Knowledge of Six Sigma methodologies (Green Belt certification preferred).
* Excellent problem-solving, analytical, and decision-making skills.
* Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
* Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
* Ability to read and interpret technical drawings and specifications.