Administrator, Quality Control

Job Title: Administrator, Quality Control

Role Level: Individual Contributor (IC)

Supervisor/Manager Title: Supervisor, Quality Control

Job Location & Environment: Irvine, CA – Cleanroom environment

Job Description Summary: Duties and responsibilities include providing administrative support for the Quality Department to ensure efficient product release for the Irvine production facility. Responsible for reviewing, completing, and archiving product DHRs and other applicable forms.

Job Responsibilities

• Administration of production documentation, records, reviewing and completing product DHR's.
• Provides general administrative support for the Quality Department.
• Supports internal and notified body audits working within the back-room team.
• Document scanning/archiving for DHR's and other quality records, documents.
• Supports other areas of the business through applicable documentation processing and electronic management of documents and records.
• Coordinates the administrations of documentations supporting the THV production. 
• Supports the site in other related projects, tasks and activities as assigned by Head of Quality. 

Required Education and Experience:

• 3 years’ experience working in a business administration role is desired.
• Experience working within a Quality Management System (QMS) ISO13485 is desired.
• Experience working in an administrative role in a highly controlled environment, such as Medical Device or Pharmaceutical, is desired.

Skills and Abilities Required for This Job:

• Proficient with standard MS Office software applications, including Word, Excel, and PowerPoint.
• Excellent computer and electronic equipment (e.g., printer/scanner) literacy, including the use of software for tracking, trending, and analysis.
• Attention to detail with strong documentation, spelling, grammar, and communication (verbal and writing) skills.
• Proficient in planning, time management and organizational skills.
• Ability to complete work independently with minimal supervision.
• Ability to collaborate with cross-functional teams.
• Ability to follow cleanroom, laboratory, and site safety protocols at all times.

Physical Requirements:

• Requires prolonged periods of standing and sitting to support inspection, testing, and review activities.
• Must be able to work in a manufacturing, laboratory, and clean room environment, including compliance with applicable gowning and PPE requirements.

Salary : $30