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    Quality Assurance Engineer III - Mississauga, Canada - Axelon Services Corporation

    Axelon Services Corporation
    Axelon Services Corporation Mississauga, Canada

    2 weeks ago

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    Description

    Quality Assurance Engineer III
    Mississauga, ON
    9- 12 Month s

    Work shift (days/times) 1st shift potential night shift depending on critical activities if needed with advanced notice. Some flexibility with nature of the project. Hours vary depending on the project

    Summary

    This role is responsible for providing tendering, manufacturing, services, repair and/or engineering project quality support in accordance with documented procedures and practices.

    Responsible for the development, implementation, improvement, and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.


    Job Description
    This position provides process support in accordance with documented global & local QMS procedures & practices.

    He/she develops the strategy for the site CAPA program to meet compliance requirements and is responsible for the development, implementation and improvement of QA practices.

    The role may involve work in CAPA, QMS processes, RCA, design transfer, manufacturing, distribution, and service.

    Provide Project Quality during tendering and project execution phases. Verify contractual and regulatory requirements are fulfilled and have maximized customer satisfaction and profitability. Establish and execute project quality plan, witness-points, quality records for compliance with contract.

    Ensure customer quality requirement, Feedback of Experience (FOE)/Lessons Learned are taken into account in the tender proposal to avoid deviation and to continually improve execution processes.


    Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills.

    Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area.

    May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters.

    A job at this level requires good interpersonal skills. For customer facing roles, develops strong customer relationships and serves as the interface between customer and Client. Explains technical information to others.


    Required Qualifications

    Bachelor's Degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience in Quality).

    Minimum of 3 additional years of experience in QA Engineering


    Desired Characteristics

    Quality Assurance/Quality Engineering experience in the Aerospace or Aviation industry or experience in design engineering or manufacturing engineering in Aerospace, Aviation or Oil and Gas field.

    Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

    Demonstrated expertise to effectively communicate within all levels of the organization around concepts of Repair/services controls, Repair/services verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

    Demonstrated collaboration & conflict resolution skills
    Excellent communication skills (written and oral)
    Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

    Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing /production process control methodologies, and servicing in a medical device environment.

    Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S, 8D)
    Experience leading and implementing change
    Experience performing internal and external audits
    Exceptional analytical, problem solving & root-cause analysis skills
    Ability to multi-task & handle tasks with competing priorities effectively
    Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
    Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
    Experience managing project teams.


    Responsibilities

    Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.

    Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.

    Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, LEAN Manufacturing, 5S, SPC, 8D, engineering studies, Gauge R&R, etc.

    Ensures process efficiency and compliance effectiveness through the development and implementation of process verifi


    Roles ancation and validation plans, including Master Router Plans (Site Level), Validation Router Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process inter dependencies with respect to process inputs, outputs, risks and impacts.


    Supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).


    Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.

    Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.


    Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.

    Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
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