Director of Quality Assurance

3 weeks ago


Irvine, California, United States OrthAlign Inc. Full time

Job Title: Director of Quality Assurance

Job Summary:

OrthAlign, Inc. is seeking a Director of Quality Assurance to oversee and implement quality control processes to ensure the delivery of high-quality products. The ideal candidate will have a strategic mindset to establish quality standards, implement product quality assurance policies, and lead a team of QA professionals.

Key Responsibilities:

  • Develop and implement product quality assurance strategies to ensure products meet customer expectations and regulatory requirements.
  • Define and document quality standards and specifications for products, ensuring alignment with customer needs and industry best practices.
  • Oversee supplier quality management processes, including supplier selection, qualification, and performance evaluation.
  • Develop and implement systems for monitoring and evaluating product quality metrics and applicable process metrics at various states of the product lifecycle.

Requirements:

  • Bachelor's degree in a related field and 10+ years of experience in quality engineering or senior manager level in quality, in a medical device environment.
  • Strong understanding of orthopedics, device software, and electromagnetic systems.
  • Demonstrated expertise interpreting and applying quality management systems to meet the requirements of ISO 13485, 21 CFR Part 820, EU MDR 2017/745, and ISO 14971.
  • Strong proficiency with Microsoft Office365 and PDF software.
  • Excellent written, verbal, and presentation communication skills.

What We Offer:

  • Competitive compensation including bonus and equity.
  • Opportunities for career advancement.
  • Full benefits package.
  • An evolving, engaging culture and workplace.


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