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    Quality Assurance Engineering Manager - Irvine, United States - PRISMATIK DENTALCRAFT, INC.

    PRISMATIK DENTALCRAFT, INC.
    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    3 weeks ago

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    Description

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell

    Essential Functions:

    • Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects.
    • Hires, manages, trains, develops, reviews, and set goals for department and staff.
    • Acts as both coach and mentor to team members in areas of problem solving, decision-making, and process improvement.
    • Addresses all employee relations matters in a timely manner in coordination with Human Resources.
    • Manages and ensures staffs adherence to Company policies and procedures.
    • Manages, modifies, and maintains a complete and comprehensive quality system to support development and contract manufacturing of medical products.
    • Oversees the technical side of the Companys quality system and processes in relation to new product development and process improvement projects.
    • Oversees the implementation of new products against market and technical standards.
    • Evaluates the product manufacturing process and systems to ensure quality standards and timely and efficient flow of assigned projects.
    • Implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
    • Participates in the reviewing of engineering designs to contribute quality requirements and considerations and supports areas in gathering and analyzing data.
    • Develops product/organizational quality assurance strategies including new European standards (MDSAP) where applicable.
    • Develops and analyzes reports related to department metrics. Prepares and presents organizational performance and technical information to the management team and associates.
    • Refines and implements quality product process plans and systems.
    • Develops and reviews standard operating procedures (SOPs) and other required policies.
    • Serves as quality engineering subject matter expert.
    • Serves as the quality representative on new product introduction teams.
    • Assures validation and compliance of contract manufacturing and sterilization facilities.
    • Manages Quality Engineering activities.
    • Organizes procedures and documentation related to areas of responsibility.
    • Participates in internal, external, and third party audits.
    • Provides technical assistance to other functional areas regarding interpretation of specifications, regulations, material qualifications, first article evaluations, and other quality related subjects to increase understanding of SOPs and guidance documentation.
    • Performs other related duties and projects as business needs require at direction of management.

    Minimum Qualifications:

    • Bachelors degree in a related engineering discipline.
    • Minimum seven (7) years of related quality assurance experience.
    • Previous management and leadership experience.
    • Advance knowledge with development and test requirements with recognized standards (ISO
    • Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach.
    • Demonstrated knowledge and understanding on regulations and guidance as related to software development, SaMD.
    • Demonstrated ability to implement and improve Software QMS processes.
    • Demonstrate knowledge of group software development methods (Agile Process and Scrum Method).

    Pay range: $112,000-$155,000/yr

    Exact compensation may vary based on skills and experience.

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