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Documentation Specialist (Quality Department) 3–6 Month As

Job ID: 1769616
OA Reference: DSVV

  • $45,800 to $54,100
  • Santa Ana, 92704

We are seeking a highly detail-oriented Documentation Specialist to support the Quality department in maintaining, organizing, and updating critical regulatory and technical documentation. This role requires exceptional administrative accuracy, strong data-entry skills, and familiarity with quality and regulatory processes.

This is an onsite, full-time contract position ideal for candidates pursuing or recently completing degrees in Quality Assurance, Regulatory Affairs, Biomedical Engineering, or related engineering fields.

Position Details

Assignment Length: 3–6 months

Department: Quality

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Hourly Rate: $23.00–$26.00

Key Responsibilities

Scan, review, and verify Device Master Records (DMR) and Device History Records (DHR)

Upload, organize, and link documents within a Quality Management System (QMS)

Ensure all records meet internal standards and FDA/ISO regulatory requirements

Maintain documentation accuracy, version control, and audit readiness

Collaborate with QA team to identify documentation gaps and support continuous compliance

Qualifications
Education

Bachelor’s degree in Engineering (Mechanical, Industrial, Manufacturing, Biomedical, or related field)

OR currently pursuing a degree in Quality Assurance, Regulatory Affairs, or related disciplines

Skills & Experience

Background in quality control, documentation, or regulatory affairs

Familiarity with DMR/DHR, quality documentation workflows, or QMS platforms

Experience with Greenlight Guru a strong plus

Understanding of FDA 21 CFR documentation guidelines

Knowledge of ISO 13485 requirements

Strong attention to detail and organizational skills

Proficiency with Microsoft Office and document scanning tools

Excellent written and verbal communication skills

Who This Role Is Ideal For

Recent graduates or students in QA/RA/Engineering seeking hands-on industry experience

Individuals who excel at document accuracy, organization, and regulatory compliance

Candidates who enjoy structure, precision, and working within quality-driven environments

Apply Today

If you are detail-oriented, motivated, and ready to contribute to a quality-driven team, we encourage you to apply.

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications 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.

Additional Skills

(none specified)

AppleOne Representative Contact Info

Account Executive:
vivian
Branch Phone:
Location:
Mission Viejo, CA