Quality Engineer - Wallingford, United States - Money Fit by DRS

    Money Fit by DRS
    Money Fit by DRS Wallingford, United States

    4 weeks ago

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    Description
    Job Summary

    Maintain and continuously improve the Quality Management System to comply with the most current quality system standards.

    The Quality Engineer is responsible for all Quality Assurance / Quality Control processes, including internal auditing, quality improvement activities, regulatory compliance, as well as interaction with customers and suppliers.

    Duties and Responsibilities

    Receive/track/investigate and respond to customer complaints including issuing RMA's

    Review and lead solutions for Non-Conformance management
    Setting up and maintaining control and documentation procedures.
    Responsible for monthly reporting of KPIs.

    Leads/supports corrective and preventative action (CAPA's) management

    Oversite of Calibration program including maintaining GageTrak

    Risk management plan and life cycle maintenance required for adherence to ISO 13485 and ISO 9001.
    Once 30,60,90 goal objectives are met position will be become a Management Representative to maintain ISO 9001 & ISO 13485 certificates

    Data analysis and trending to drive continuous improvement

    Formulating and manage the development and implementation of goals, objectives, policies, procedures for QMS standards.
    Approving and facilitating customer required validation activities

    Education

    Min/Preferred

    Education Level

    Description

    Required

    Associates or 4 Year / Bachelor's Degree

    Engineering or related field.

    Experience

    Min/Preferred

    Experience

    Description

    Required

    2 years

    Quality Management System.

    KSA's

    Strong problem solving, decision making, and process improvement skills.
    Excellent interpersonal and communication skills.

    Ability to determine and meet deadlines.

    Ability to work independently as well as part of a team.

    Analytical thinking skills.

    Strong understanding of quality systems, ISO 9001 & ISO 13485

    Physical Demands

    Demand

    Frequency

    Sitting

    Frequent

    Standing

    Frequent

    Walking

    Frequent

    Use hand/fingers to grasp/pinch/grip

    Occasional

    Climbing (stairs/ladders) or balancing

    Not Applicable

    Stoop, kneel, crouch, or crawl

    Not Applicable

    Operating machinery and/or power tools

    Occasional

    Operating motor vehicles or heavy equipment

    Not Applicable

    Activity

    Weight Demand

    Frequency

    Lift

    15-20lbs

    Occasional

    Carry

    15-20lbs

    Occasional

    Push

    15-20lbs

    Occasional

    Pull

    15-20lbs

    Occasional

    Work Environment

    Work performed in an office environment. The noise level in the work environment is usually low.

    May be exposed to production floor environment. The noise level on the production floor can be loud.

    Disclaimer


    Clayens, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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