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Compliance Head - Quality Assurance
RxSight, Inc. - Aliso Viejo, CA

 

 

 

OVERVIEW:

The Compliance Head is responsible for leading the internal audit program, external audit management, certification programs, recall and field safety corrective action programs, management review, external standards compliance, and quality system compliance reviews of change control submissions. They are also responsible for interactions with Health Authorities and Notified Bodies with respect to audits and quality system/site registrations. The Compliance Head is also responsible for leading management reviews and performing compliance activities with respect to regulations. The Compliance Head supports the day-to-day operations of Quality Assurance and Quality Control with respect to complaints, investigations, CAPA, training, change control, product release, etc. The compliance head is responsible for reviewing all design history files for completeness and reviewing change controls for regulatory impact.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Compliance for audits, site registrations, and quality system certifications
  • Internal audits
  • Lead recall and field safety corrective actions
  • Management Review
  • Design History File creation and support
  • Engineering Change Request support
  • Risk Management of products both on market and in development support
  • Supplier qualifications and audits
  • Assisting management with ad-hoc reports as required
  • Completing CAPA’s, complaint investigations, non-conformances, training, change controls, product releases as required
  • Support day-to-day operations of the Quality Assurance and Quality Control groups
  • Lead quality improvement initiatives
  • Provide oversight of the product lines both in development and in manufacturing for compliance to relevant standards and quality system regulations including but not limited to FDA, ISO, IEC, ANSI, AAMI, CMDCAS, COFEPRIS, TGA, ANVISA, etc.
  • Ensure post-market compliance programs for vigilance reporting are compliant to United States and international requirements as applicable

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11
  • Knowledgeable of ISO 13485
  • Knowledgeable of IEC 60601-1 and ISO 14971
  • Knowledgeable of requirements for medical devices in US, EU, Mexico, Canada, Australia, and other markets
  • Knowledgeable of vigilance reporting requirements and field safety corrective actions
  • Able to perform product failure analysis
  • Able to perform basic statistical analysis
  • Able to handle conflict management and resolution
  • Able to run complaints, CAPA, training, non-conformances, change control, engineering change requests, and other quality systems
  • Able to speak well in front of executives for management review
  • Support creation of regulatory submissions as required

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION, EXPERIENCE, and TRAINING:

  • Minimum of Bachelor’s degree in scientific or technical field (Engineering, Biology, Chemistry, etc.) with at least ten years of experience in related field (if with a Master’s degree then with at least five years of experience in the field)

CERTIFICATES, LICENSES, REGISTRATIONS:

  • ASQ certification recommended but not required

COMPUTER SKILLS:

  • Competent in use of spreadsheets and documents
  • Competent in preparing presentations

ABOUT THE COMPANY:

RxSight, Inc. – a privately-funded medical device company headquartered in Aliso Viejo, California – has developed breakthrough intraocular lens technology for use in cataract and lens replacement surgery. Cataract surgery is one of the most commonly practiced surgical procedures with approximately 25 million surgeries performed globally each year.

The company has developed the first adjustable intraocular lens that allows non-invasive visual optimization after lens implantation and healing. Unpredictable refractive error after cataract surgery is common, even with the latest diagnostic and intraocular lens technology. The only options available for addressing the residual error are glasses, contact lenses, or additional invasive surgery.

Using a proprietary photosensitive lens material, RxSight’s Light Adjustable Lens (RxLAL®) provides a powerful alternative. Instead of prescribing corrective lenses (glasses or contacts), physicians can apply the patient’s personalized prescription directly into the adjustable intraocular lens in an office-based procedure. This approach will enable physicians to prescribe customized solutions for all distances that fit each cataract patient’s individual needs and preferences.

The Premarket Approval (PMA) application for the RxLAL has been submitted to the United States Food and Drug Administration (FDA). The Company has assembled a world-class executive team of ophthalmic industry veterans, and has the leadership, resources, and technology in place to transform the worldwide cataract surgery market.

Job Type: Full-time

Job Location:

  • Aliso Viejo, CA

Required education:

  • Bachelor's

Required experience:

  • Quality Assurance: 10 years

 

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