Quality Assurance Engineer - Trenton, Canada - APTYX (GlobalMed)

    APTYX (GlobalMed)
    APTYX (GlobalMed) Trenton, Canada

    2 weeks ago

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    Human Resources
    Description

    To support its growth strategy, Aptyx GlobalMed is seeking to fill the role of a Manufacturing Quality Engineer. We are looking for an industry experienced individual who will hit the ground running. Reporting to the Quality Assurance & Regulatory Affairs Manager, the successful candidate will be involved in APQP and process quality control and related aspects including continuous improvement, issue resolution, preventative and corrective actions, product launch, Change Request etc

    The main responsibility of the Quality Engineer is to ensure quality standards in the raw materials and products produced by the company. Quality Engineer will assist in continuous improvement, research and development, engineering, and product realization initiatives as a representative for quality and drive changes to completion.

    The Quality Engineer will manage the internal audit process.

    Duties:

    Develops and implements methods for sampling, inspection, testing and evaluation of products.

    Investigate customer product complaints, and work with Quality, production, and Engineering teams to pursue a resolution.

    Leads and Participates in Advanced Product Quality protocols, including PPAP and FAI

    Assists in improving and establishing an effective Quality Management System to control and ensure the quality of products as well as incorporating risk management into the QMS.

    Supports research and development, product realization, technical engineering, and manufacturing departments to ensure successful transition of products and processes from design to production.

    Organize and manage the internal audit system.

    Conduct tests (e.g., hypothesis testing, normal distribution testing, and so on) and analyzing data derived from the tests. Troubleshoots problems with items that were involved in doing the tests. Prepare reports based on tests and research and come up with recommendations to improve quality.

    Provides support to the investigation of non-conformance reports, customer complaints and CAPA.

    Develop, track and prepare monthly reports for internal and external quality performance metrices.

    Employment and Educational Requirements:

    Minimum 5 years' experience in a manufacturing and Quality Engineering capacity.

    Organized and detail oriented with a process mindset to spot variability.

    Strong work ethic and initiative – an independent self-starter.

    Ability to create and execute project plans through to completion.

    Customer focused – understands deadlines, works with internal and external customers.

    Good communication and interpersonal skills.

    Solution and problem solving oriented. Able to manage multiple projects.

    Proficient in Inspection Methods (Measurement & Evaluation), Geometric Dimensioning and Tolerance (GD&T), blueprint reading, 8D, Pareto, statistical analysis (SPC), proficient in product qualification Methodology (PPAP, FMEA, APQP, Control Plans).

    Appropriate education, training and working experience in use of QA methodologies. Practical experience with risk management, product testing, capability studies, and control plans.

    Excellent attention to detail

    Familiarity with policy, procedural and technical writing

    Dedication to continuous learning and remaining up to date in the newest manufacturing and Quality regulatory requirements.

    Working conditions:

    Office and production floor environment, computer and desk work as required. Onsite only (not hybrid)

    Our organization is committed to creating a diverse environment and to be an equal opportunity employer. We will provide reasonable accommodation for disabilities to support the participation of candidates in all aspects of the recruitment process when requested.Only qualified applicants under consideration will be contacted for an interview.