Director of Quality Systems

Company: Jobot
Location: Irvine
Posted on: May 28, 2023

Job Description:

EXCITING Director of QA and Quality Systems - Remote Flexibility - Excellent Culture and Compensation $$$This Jobot Job is hosted by: Sean CarneyAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $125,000 - $225,000 per yearA bit about us:Growing medical device healthcare company with impactful results! Using the precision of trusted excimer laser technology, studies have shown that the procedure has been effective in lowering eye pressure, offering patients and healthcare professionals a glaucoma treatment that lasts.Why join us?

• Excellent Work Life Balance
• AWESOME Opportunity for growth
• Direct Interaction with Leadership
• 401k
• PTO / Time Off Packages
• Equity - Stock Options!!Job DetailsWe are seeking a highly motivated and experienced Director of QA & Quality Systems to join our dynamic and innovative team in the medical industry. The successful candidate will be responsible for ensuring that our medical devices meet the highest standards of quality and safety. This is a full-time position that requires a minimum of 6 years of experience in medical device quality assurance.Responsibilities:
  • Develop and implement quality systems and processes to ensure compliance with all relevant regulations and standards, including ISO 13485, ISO 14971, and FDA requirements.
  • Lead the Global QA Team to ensure that all product quality issues are addressed in a timely and effective manner.
  • Manage the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget.
  • Maintain and update all QA documentation, including procedures, work instructions, and forms.
  • Ensure that all Class II and Class III Medical Devices are manufactured and distributed in compliance with all regulatory requirements.
  • Develop and implement quality control systems to monitor product quality and identify opportunities for improvement.
  • Provide leadership and guidance to the QA team to ensure that all employees are trained and equipped to perform their roles effectively.Qualifications:
    • Bachelor's degree in a relevant field, such as engineering, science, or quality assurance.
    • Minimum of 6 years of experience in medical device quality assurance or a related field.
    • Strong knowledge of ISO 13485, ISO 14971, and FDA regulations.
    • Experience managing a Global QA Team.
    • Experience with Class II and Class III Medical Devices.
    • Strong analytical and problem-solving skills.
    • Excellent communication and interpersonal skills.
    • Ability to work independently and as part of a team.
    • Strong attention to detail and a commitment to quality.
    • Ability to prioritize and manage multiple projects simultaneously.If you are passionate about quality and have the experience and skills required for this position, we encourage you to apply today!Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

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