Quality Analyst

Jabil - Maple Grove, MN

Full-time - Mid Level

Maple Grove, MN

1,001-5,000 employees

Computer and Electronic Product Manufacturing

About the position

The Quality Analyst at Jabil is responsible for ensuring compliance with established document control procedures and providing guidance to stakeholders. This role involves managing the document control process, overseeing change control, and maintaining quality training programs. The Quality Analyst plays a critical role in supporting audits and ensuring adherence to industry standards such as ISO 13485 and 21 CFR part 820.

Responsibilities

• Administer the document control process as the site Subject Matter Expert (SME).
• Lead the administration of the change control process and act as the Change Control Administrator.
• Report weekly to management on change control statuses.
• Administer deviations for review and approval, interfacing with customers regarding deviations via their electronic document control system.
• Administer training for the site and maintain a quality training matrix.
• Conduct training on quality-related subjects such as Good Documentation Practices (GDP), Document Control, and Change Control.
• Manage the Quality Record retention process, including logging, filing, and sending records off-site to an approved vendor.
• Develop, review, and implement new procedures, work instructions, and other documents as needed.
• Oversee control of documentation in compliance with ISO 13485 and 21 CFR part 820.
• Support internal, corporate, notified body, FDA, and other audits.

Requirements

• Bachelor's degree in a relevant field.
• 3 years of experience in a manufacturing quality or engineering environment.
• Master's degree in Mathematics/Statistics preferred.
• Six Sigma Black Belt certification preferred.

Nice-to-haves

• Experience with electronic document control systems.
• Knowledge of FDA regulations and compliance standards.

Benefits

• Comprehensive health insurance coverage.
• 401k retirement savings plan.
• Paid time off and holidays.
• Professional development opportunities.