Quality Assurance Specialist

4 weeks ago


Irvine, California, United States Yoh Full time
Quality Assurance Specialist

This role will support the compilation and maintenance of IVDR technical files, review IVDR and other registration labeling change requests, and perform various quality tasks to support the QMS overall.

Responsibilities:
  • Review, approve, and process labeling and FOC change requests
  • Compile, create, review, and update quality-related technical file documentations
  • Perform various quality tasks such as LS FOC creation, non-labeling related change requests, etc.

Requirements:
  • Basic understanding of GMP and quality system standards
  • Proficient in Microsoft Office (Word, Excel, etc.)
  • Detailed-oriented with the ability to multi-task

What We Offer:
  • Medical, Dental & Vision Benefits
  • 401K Retirement Saving Plan
  • Life & Disability Insurance
  • Direct Deposit & Weekly ePayroll
  • Employee Discount Programs
  • Referral Bonus Programs

Estimated Pay Range: $25.20 - $36.00

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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