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    Director of Quality - Santa Clarita, United States - Valencia Technologies

    Valencia Technologies
    Valencia Technologies Santa Clarita, United States

    4 weeks ago

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    Description
    Job Description

    Job Description


    Position/Title:
    Director of Quality

    Department:
    Quality Assurance

    Supervisor:
    Senior Director, Regulatory and Clinical Affairs

    FLSA Status:
    Exempt


    About the Company:


    Valencia Technologies is a neuromodulation company transforming the standard of care for urgency urinary incontinence with the development of our revolutionary eCoin technology.

    With recent FDA approval, Valencia Technologies is ramping up all aspects of business to deliver effective therapy and impact the lives of millions.

    Join our mission to become the market leader in overactive bladder care as we bring patients and physicians a better therapy now and beyond, put patients first, and be a place of respect, excellence, and honesty for our employees and clients.


    Job Summary:
    This employee is responsible for ensuring that the Quality System meets the needs of the company, is compliant to established

    standards/regulations,

    and helps to continuously improve the efficiency and effectiveness of the quality system.


    Responsibilities/Tasks:
    As Director of Quality, you will be responsible for:
    Manage Quality Systems processes such as CAPA, Document Control, Internal Audit, and complaint handling.
    Leading external audits.
    Providing significant guidance and approval regarding development and manufacturing projects.
    Serves as Quality Management Representative

    Provides guidance and decisions on Operations and Design Control activities to ensure continued compliance with internal procedures, regulatory requirements, and standards.

    Trains, recruits and maintains high quality staff
    Leading the decision-making process for recall/field actions
    Provide tactical and strategic direction on Quality-related matters
    Ensuring the department has the leadership and resources to achive the company's objectives
    Interfacing to external entities on behalf of the Quality department

    Duties include the exercise of discretion and independent judgment with respect to matters of significance.


    Competencies:

    Action Oriented:

    Displays high energy and enthusiasm on consistent basis, exhibits personal ambition and drive but not at expense of others.


    Analysis of Data:
    Ability to analyze and challenge data prior to making decisions
    Analytical/Critical

    Thinking:

    Able to breakdown raw information and undefined problems into specific, workable components that in-turn clearly identifies the issues at hand.

    Makes logical conclusions, anticipates obstacles, and considers different approaches to the decision-making process.

    Attention to Detail:
    Sees and pays attention to details; recognizes the component parts of a procedure or object; verifies the correctness or error in an individual part or procedure

    Initiative:
    Takes action, seeks new opportunities, strives to see projects to completion

    Interpersonal Skills:
    Builds strong relationships, is

    flexible/adaptable,

    works well with others, solicits feedback

    Persistence:
    Staying the course in times of difficulty; remaining motivated to accomplish goals in the face of adversity or obstacles

    Problem Solving:
    Strives to understand contributing factors, works to resolve complex situations

    Resilience:
    Bounces back from daily crisis, disappointments and frustrations

    Teamwork:
    Accountable to team, works to meet established deliverables, appreciate view of team members, respectful


    Qualifications:
    Strong expertise of Quality Systems 21 CFR 820 and ISO 13485
    Working knowledge of Word and Excel
    Must have a BS in a science or engineering discipline
    Must be able to work independently and collaborate with team members
    Minimum of 8 years of related experience
    Excellent written and presentation skills


    Benefits:
    Medical Insurance
    Dental Insurance
    Vision Insurance
    401K with Employer Matching
    Paid Time Off
    Paid Holidays
    Professional Development Reimbursement
    Annual Bonus Eligibility

    Valencia Technologies is proud to be an equal opportunity workplace and is an affirmative action employer

    #J-18808-Ljbffr

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