Spec QA Sterilization (Medical Devices)

Location: Wuhan, China

Company

hirify.global is the employing organization for this role.

What you will do

• Review sterilization documentation against current agreements and release sterilized products when all sterility acceptance criteria are met.
• Collect, track, and analyze release data; issue trending reports and maintain the sterilization database.
• Manage, supervise, and train sterilizers on compliant sterilized product release procedures.
• Issue, track, and close SCAR and deviation/non-conformance reports for supplier-related release issues.
• Issue CAPA under supervision and support CAPA tracking and closure.
• Support validation activities and maintain sterilization processing agreements.

Requirements

• Ability to review sterilization records and determine whether sterility release criteria have been achieved.
• Ability to manage supplier-related SCAR, deviation, non-conformance, and CAPA activities.
• Ability to maintain quality databases, analyze release data, and prepare trend reports.
• Ability to supervise and train personnel in sterilized product release procedures.

Culture & Benefits

• Full-time employment.
• Health insurance, life and disability insurance, 401(k) contributions, and paid time off are available to employees working an average of 30 or more hours per week.
• Employees working fewer than 30 hours per week receive 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
• Focus on inclusion, belonging, career growth, and providing resources for effective work.