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    Quality Sr Engineer II - Montreal, Canada - Zimmer Biomet

    Zimmer Biomet
    Zimmer Biomet Montreal, Canada

    2 weeks ago

    Default job background
    Full time
    Description
    Chez Zimmer Biomet, nous croyons qu'il faut repousser les limites de l'innovation et faire avancer notre mission.

    En tant que leader mondial de la technologie médicale depuis près de 100 ans, la mobilité d'un patient est améliorée par un produit ou une technologie Zimmer Biomet toutes les 8 secondes.

    En tant que membre de l'équipe Zimmer Biomet, vous partagerez notre engagement à fournir mobilité et vie renouvelée aux personnes du monde entier.

    Pour soutenir notre équipe de talents, nous nous concentrons sur les opportunités de développement, les groupes de ressources d'employés (ERG) solides, un environnement de travail flexible, des récompenses totales compétitives spécifiques au site, des incitations au bien-être et une culture de reconnaissance et de récompenses de performance.

    Nous nous engageons à créer un environnement où chaque membre de l'équipe se sent inclus, respecté, responsabilisé et reconnu.

    Promesses

    What can you expect


    Contribute to maintaining Quality Management System (QMS) compliance to ensure efficiency and compliance with national and international medical device regulations.

    Comment créer un impact

    How you'll create impact


    Maintain FDA QSR (Quality System Regulation) standards and regulations, ISO 13485: 2016, MDSAP country requirements, as well as integration of all applicable global medical device regulatory requirements.

    Lead the preparation and execution of internal audits.

    Lead the preparation of third-party or external certification audits to demonstrate compliance with GMP, ISO and EU MDR regulations, QSR, Health Canada regulations, and other countries, as applicable.

    Participate in or lead the implementation of quality improvement projects or the introduction of automated quality systems.

    Manage the conduct of root cause investigations, the implementation of corrective and preventive actions, and compliance with established deadlines.


    Work closely with design, quality, manufacturing, and other departments to ensure that QMS requirements are effectively established and maintained, with a proactive and preventive risk-based approach.

    Ensure the relevance, adequacy, and effectiveness of the QMS and report periodically on quality system performance. Evaluate opportunities for improvement and lead established initiatives and action plans.

    Ce qui fera la différence

    What makes you stand out

    Practical knowledge and experience in internal auditing as well as external audits and regulatory inspections. Skills as an audit manager are an asset.

    In-depth knowledge of quality system regulations and medical device regulations and standards


    Results-oriented approach, the incumbent must demonstrate the ability to deliver and meet deadlines while maintaining the highest level of product quality.

    Ability to work in a team environment and build relationships outside the department.

    Facilitate team efforts on quality engineering and compliance projects.

    Able to communicate, in French and English, both orally and in writing, at several levels of the company.

    Microsoft Office Suite.

    Votre parcours

    Your background

    Bachelor's degree in engineering, biology, pharmacy or alternative degree program with certification as a quality engineer (e.g. ASQ, Exemplar).


    5 to 10 years' experience in quality assurance, preferably in the medical device sector, or an equivalent combination of training and experience.

    Attentes en matière de déplacement

    Travel expectations

    Up to 10%.

    A current passport is required.

    EOE/M/F/Vét./Incapacité
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