Quality Assurance Specialist

5 days ago


Aliso Viejo, California, United States RXSIGHT INC Full time
Job Description

RxSight Inc. is a leading ophthalmic medical technology corporation that has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery.

Job Summary:

We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our Quality Systems & Compliance team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.

Key Responsibilities:

  • Develop a comprehensive understanding of all our products and devices while collaborating with cross-functional teams to ensure business continuity.
  • Gain proficiency in using and troubleshooting various electronic systems, including eQMS, SmartSheets, and Microsoft Office.
  • Support the maintenance of quality compliance, including document control, employee training, and on/off boarding.
  • Monitor and support compliance with standards, corporate policies, and industry regulations.
  • Identify and implement innovative and creative ways to improve and streamline practices and operations as our company grows.
  • Assist with internal and external audits.

Requirements:

  • Knowledge of quality systems and medical device compliance is preferred.
  • Knowledge of ISO 13485, 11979, 14971, and 21 CFR 820/Part 11.
  • Individual with a curious and passionate mindset, keen on problem-solving, detail-oriented, and strong teamwork and communication skills.
  • Capable of training others with diverse backgrounds and learning styles.
  • Strong adaptability and flexibility to handle daily changes.

Education, Experience, and Training:

  • Minimum of 3-4 years of relevant work experience.
  • Microsoft Word; Microsoft Excel.
  • QAD and experience a plus.
  • Must be a US citizen or Permanent Resident of US (Green-card).
  • Proficient with Microsoft office tools.
  • Good decision-making, organization skills, problem-solving skills, and teamwork-oriented.


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