Quality Lead I (Medical Devices)

Location: Onsite in Irvine, California, United States. Regular and predictable onsite attendance is required. Schedule: Sunday–Thursday, 9:00 PM–5:30 AM. Relocation is not available.

Salary: $30.28–$36.08 per hour.

Company

A global healthcare company developing, manufacturing, and marketing infusion therapy, pain management, nutrition, pharmacy, ostomy, wound care, and dialysis products.

What you will do

• Coordinate label room and chain-of-custody activities, including issuing production materials and routing samples to laboratories.
• Perform process monitoring, labeling control, reinspection monitoring, and reserved-sample activities.
• Provide quality oversight of manufacturing processes, including data integrity compliance.
• Provide work direction and training to Quality Operations Associates.
• Support quality investigations and resolution of quality issues, escalating concerns to the Supervisor when required.
• Support recertification of BU PM inspectors.

Requirements

• High school diploma required; a Bachelor's degree in a science-related field is preferred.
• At least 4 years of related experience required.
• Ability to work onsite in Irvine and maintain regular, predictable onsite attendance.
• Ability to work a non-standard schedule, including the Sunday–Thursday overnight shift.
• Working knowledge of the relevant technical field and established procedures and guidelines.
• Ability to use limited judgment in resolving problems and occasionally assist with training and checking peer work.

Culture & Benefits

• Healthcare benefits.
• 401(k) plan.
• Tuition reimbursement.
• Continuous-improvement focus through the Sharing Expertise initiative.
• Work involving healthcare product quality, patient safety, and environmental safety.