Quality Assurance Engineering Manager

6 days ago


Irvine, California, United States PRISMATIK DENTALCRAFT, INC. Full time
About the Role

At Prismatik Dentalcraft, Inc., we are seeking a highly skilled Quality Assurance Engineering Manager to join our team. As a key member of our organization, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Quality Management: Develop and implement quality management systems to ensure products meet customer requirements and comply with US and international regulations.
  • Leadership and Team Management: Hire, manage, train, develop, review, and set goals for the Quality Assurance team.
  • Process Improvement: Manage new product development and process improvement projects to enhance efficiency and quality.
  • Regulatory Compliance: Ensure adherence to Company policies and procedures, as well as regulatory requirements for low-risk and high-risk software applications.
  • Technical Expertise: Oversee the technical side of the Company's quality system and processes, including new product development and process improvement projects.
  • Quality Engineering: Develop and implement quality product process plans and systems, and refine and improve existing processes.
  • Documentation and Reporting: Develop and review standard operating procedures (SOPs) and other required policies, and prepare and present organizational performance and technical information to the management team and associates.
  • Quality Assurance: Ensure validation and compliance of contract manufacturing and sterilization facilities, and manage Quality Engineering activities.
  • Collaboration and Communication: Participate in internal, external, and third-party audits, and provide technical assistance to other functional areas regarding interpretation of specifications, regulations, material qualifications, first article evaluations, and other quality-related subjects.
Requirements
  • Education: Bachelor's degree in a related engineering discipline.
  • Experience: Minimum seven (7) years of related quality assurance experience, including previous management and leadership experience.
  • Skills and Knowledge: Advanced knowledge of development and test requirements with recognized standards (ISO), previous quality assurance experience in materials manufacturing, and previous experience with New Product Development.
  • Regulatory Knowledge: Demonstrated knowledge of the application of regulatory requirements for low-risk and high-risk software applications using a scalable approach, and demonstrated knowledge and understanding of regulations and guidance as related to software development, SaMD.
What We Offer

We offer a competitive salary range of $111,956-$155,000/yr, and exact compensation may vary based on skills and experience.



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