• Quality Anaylst Technician

    Job Locations CA-ON-Ottawa
    Posted Date 3 weeks ago(5/31/2018 7:16 AM)
    Job ID
    2018-2210
    # of Openings
    1
    Category
    Quality
    Business
    ME - Med-Eng
    Employee Type
    Regular Full-Time
    Position Level
    Associate
  • Overview

    Ensure the ongoing effectiveness and compliance of the Quality Management System (QMS) to the requirements of ISO 9001 (latest version), assist in all aspects of the QMS and with maintenance of the system by conducting regular internal audits. This includes audit planning, coordination with other Med-Eng facilities, execution and follow-up. In addition, support Quality Assurance and Control activities through management of the Ottawa facility calibration program, coordination of product testing, quality planning for control at incoming, in-process, final and / or source inspections as well as program and project support.

     

    Responsibilities

    Duties & Responsibilities – Quality Systems:

    • Assist with Business Process document control;
    • Train new auditors;
    • Responsible for planning executing internal audits to the current ISO 9001 Standard including co-ordination of efforts between all Med-Eng facilities;
    • Responsible for conducting Internal Audits including process audits;
      • Plan/conduct audit/document findings and prepare audit final report
      • Communicate results to department(s) audited and to QA Management
      • Work with the audited department(s) to assist in resolution of compliance issues
      • Perform necessary follow-up including communicating with audited department(s) management on status of corrective action implementation and verification
      • Communicate to management issues that require attention
      • Maintain files generated from each audit
    • May be required to assist in on-site audit of supplier’s quality management system;
    • Other duties may be assigned.

    .

    Duties & Responsibilities – General:

    • Support Product Quality Specialists by conducting product audits and inspections, including required product sampling, complete necessary reports, including Certificate of Compliance, material discrepancy, and part inspection records, etc.
    • Evaluate supplier’s ability to provide product, process or service.
    • Work with asset owner and purchasing to coordinate addition of new assets into the system, internal and external calibration of inspection, measuring and test equipment. Create, maintain and update asset records in compliance management application (Q-Pulse)
    • Coordinate internal and external testing of Med-Eng product as part of certification and/or internal product surveillance requirements. Update test records in compliance management application (Q-Pulse).

     

    Qualifications

    • Strong knowledge of ISO 9001:2015 standard and auditing requirements
    • Ability to read and interpret, Engineering drawings, assembly documents, work instructions Certificates of Conformance / Analysis, procedure manuals, contracts, SOWs, etc.;
    • Ability to communicate effectively verbally and in writing;
    • Strong knowledge on calibration program requirements and management;
    • Capable of coordinating activities of internal audit team and conducting directed audits of business processes;
    • Proficient in the use of MS Office Suite and able to generate effective reports and communications, i.e., emails, power point presentations, procedures;
    • Ability to review corrective actions for effectiveness and verify same;
    • Ability to define problems, collect data, establish facts and draw valid conclusions;
    • Energetic and willing to work in a team environment;
    • Able to design and implement process improvements and coach other departments;
    • Ability travel locally and internationally;
    • Five (5) to seven (7) years’ experience in Quality Inspection and Auditing within an Engineering and manufacturing environment and/or training or equivalent combination of education and experience;
    • Certified Lead / Internal auditor preferred from recognized training facilities or quality organizations (e.g. ASQ).

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