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    Manager - Quality Assurance Engineering - Irvine, United States - Prismatik

    Prismatik
    Prismatik Irvine, United States

    3 weeks ago

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    Description

    Job Description

    Job Description
    Essential Functions:
    • Guarantees that products fulfill customer requirements and comply with regulations. Manages projects for new product development and process enhancement.
    • Recruits, leads, trains, develops, evaluates, and sets objectives for department and staff.
    • Acts as a mentor to team members in problem-solving, decision-making, and process enhancement.
    • Handles all staff relations matters promptly in collaboration with Human Resources.
    • Ensures staff's compliance with Company policies and procedures.
    • Creates and maintains a comprehensive quality system to support the development and manufacturing of medical products.
    • Supervises the technical aspects of the Company's quality system and processes for new product development and process enhancement projects.
    • Oversees the introduction of new products in accordance with market and technical standards.
    • Evaluates the manufacturing process and systems to maintain quality standards and efficient project flow.
    • Establishes methods for inspecting, testing, and assessing product precision and equipment accuracy.
    • Provides input on engineering designs to address quality requirements and supports data analysis.
    • Develops quality assurance strategies including new European standards (MDSAP) where applicable.
    • Prepares and presents performance and technical information to management and associates.
    • Implements quality product process plans and systems.
    • Reviews standard operating procedures (SOPs) and necessary policies.
    • Acts as quality engineering subject matter expert.
    • Represents quality on new product introduction teams.
    • Ensures contract manufacturing and sterilization facilities' validation and compliance.
    • Manages Quality Engineering activities.
    • Organizes procedures and documentation for assigned responsibilities.
    • Participates in audits.
    • Provides technical support regarding specifications, regulations, material qualifications, and other quality areas.
    • Performs additional duties and projects as needed.
    Minimum Qualifications:
    • Bachelor's degree in a related engineering field.
    • Minimum 7 years of quality assurance experience.
    • Prior management and leadership experience.
    • Advanced knowledge of development and test requirements with recognized standards (ISO 13485).
    • Knowledge of regulatory requirements for software applications.
    • Ability to implement and enhance Software QMS processes.
    • Knowledge of 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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