Quality Assurance Specialist
5 days ago
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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