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Posiciones disponibles

  • 26 junio 2019
    Quality Operations Coordinator

    MEDXL INC.

    POSITION DESCRIPTION

    TITLE : Quality Operations Coordinator

    Employee’s name:

    Department: Quality Operations

    SUPERVISOR TITLE : Supervisor

    DATE:   

    TASKS AND RESPONSIBILITIES

     

    ·         Understand the priorities assigned by the supervisor.

    ·         Plan the work according to the schedule of the tests.

    ·         Perform tests during production, complete documentation for the tests and classify documentations.

    ·         Perform the tests on finished products for production lots to be released.

    ·         Ensure compliance for the products and issue the certificate of analysis.

    ·         Participate in problem-solving and decision-making relating to inspections carried out.

    ·         Perform environmental controls (microbiological, particulate, temperature, humidity and pressure).

    ·         Read data from environmental particulate controls.

    ·         Save the date in the corresponding documents and submit them to the service of quality operations for cross-checking.

    ·         Analyze the samples returned by the customer after customer complaints.

    ·         Participate in the selection and approval of new components.

    ·         Responsible for the development of the quality control tests for components used in the manufacture in collaboration with engineering and quality operations according to the normative requirements.

    ·         Produce the assembly drawing of new products according to the components provided by engineering.

    ·         Coordinate laboratory tests.

    ·         Participate in the development of the quality control tests for finished products and production in collaboration with engineering and operations quality according to the normative requirements.

    ·         Responsible for the update of the classified products table to the risk factor (measure of the products surfaces, products and components weight and number of components by product).

    ·         Responsible for the follow-up of requests for changes and non-conformities.

    ·         Write and review of quality operations procedures.

    ·         In charge of training new department employees on the implemented quality system.

    ·         Responsible for managing the quality system documents to ensure that it complies with the standards and regulation.

    ·         Responsible for the follow up of the documentary change requests approved by the supervisor.

    ·         Participate in qualifying and selecting suppliers in collaboration with engineering and procurement.

    ·         Manage complaints from suppliers and customers.

    ·         Follow up on CAPA and non-conformities.

    ·         Participate in the validation of process records.

    ·         Participate in the drafting of procedures for standard operations (PON).

    ·         Verify the fabrication file to allow the release of the fabrication lots and allow issuance of certicate of conformity.

    ·         Participate in internal and external audits.

    ·         Follow up of sterilization dose audit program.

    ·         Be part of the department meetings.

    ·         Perform all other related tasks.

     

     

    QUALIFICATIONS

     

    ·         Retain a DEC in science and have a minimum of 2 years’ experience in quality field or retains BSC diploma in science.

    ·         Retain good knowledge of current business software.

    ·         To master the good manufacturing practices (GMP).

    ·         To be able to write French and English.

    ·         To have knowledge of the 13485 standard.

    REQUIREMENTS

     

    ·         To be adaptable, on time, stress resistant and meticulous.

    ·         To be able to learn and to work in a team.

    ·         To have good working and analysis capacities, initiative, judgment and a good working organization.

    PROBATION PERIOD

     

    ·         6 months.

     

     

     

     

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