QA/RA Student Position

4 hours ago

Kfar Saba Center District, Israel Annabella Full time ₪32,000 - ₪40,000 per year

Annabella
 is a non-traded public company that markets a unique breast pump with a patented mechanism designed to imitate the baby's natural suckling. By replicating the tongue motion of the baby's mouth, Annabella extracts 
1.5X more milk
 more efficiently, fast, and pain-free.

The Role

We are seeking a highly organized QA/RA student who is a motivated self-learner, detail-oriented, and comfortable working with documentation to support our ongoing quality and regulatory activities. You will work closely with the QA/RA Lead and the engineering teams to ensure our processes and documentation meet global regulatory requirements. This is an excellent opportunity to gain hands-on experience in the medical device industry, understand the full lifecycle of a product, and learn about international standards (ISO 13485, FDA, EU and UK Directives).

Key Responsibilities

  • Documentation Control:
     Assist in maintaining and updating the technical files of the company (DHF, DMR, DHR, etc).
  • Regulatory Support:
     Support the preparation of regulatory submissions and technical documentation for international markets (CE, FDA, etc.).
  • Testing & Validation:
     Participate in V&V (Verification and Validation) protocols execution and report generation.
  • Process Improvement:
     Assist in handling customer complaints, CAPAs (Corrective and Preventive Actions), and Non-Conformances.
  • Audit Preparation:
     Help the team prepare for internal and external quality audits.
  • Ongoing tasks assigned according to the company's evolving needs.

Requirements

  • Education:
     Currently enrolled in a B.Sc. degree in Biomedical Engineering, Biotechnology, Quality Engineering, or a related field (at least 3 semesters remaining).
  • Availability:
     Able to work 3 days per week
    - must.
  • Language Skills:
     Excellent written and spoken English.
  • Technical Skills-
     Proficient in Microsoft Office (Word, Excel, PowerPoint).

Nice to Have:

  • Familiarity with ISO 13485 or FDA QSR regulations.
  • Previous experience in QA/RA roles.

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