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Sr. Supplier Quality Engineer - Montreal - Medtronic
Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life
À propos du rôle
En tant que membre de l'équipe d'Assurance Qualité des Fournisseurs au site de Pointe Claire, vous serez responsable de la gestion des fournisseurs externes, essentiels à la fabrication des dispositifs produits sur notre site. Vous superviserez les produits fournis, gérerez les relations avec les fournisseurs, mettrez en œuvre les changements et favoriserez l'amélioration continue. Votre rôle garantira la conformité aux exigences des matériaux achetés et la gestion des produits non conformes en respectant les procédures d'achat et de contrôle des fournisseurs de Medtronic, les exigences des organismes de régulation, les normes internationales et les règlements du système qualité.
Job Specific Summary
As a member of Supplier Quality Engineering at the Pointe Claire facility, you will be responsible for managing external suppliers, integral to the devices produced at our site. You will oversee supplied products, manage supplier relationships, implement changes, and drive improvements. Your role will ensure conformance to purchased material requirements and manage nonconforming products in compliance with Medtronic Purchasing and Supplier Controls, regulatory bodies, international requirements, and Quality System Regulations.
Description Du Poste
Chez Medtronic, vous pouvez commencer une carrière de toute une vie basée sur l'exploration et l'innovation, tout en contribuant à promouvoir l'accès et l'équité en matière de soins de santé pour tous. Vous dirigerez avec un objectif, en brisant les barrières à l'innovation dans un monde plus connecté et compatissant
Responsabilités Principales:
Maintenir la continuité de l'approvisionnement des composants achetés auprès des fournisseurs tout en assurant la qualité des pièces, des matériaux et des services.
Qualifier les fournisseurs selon les normes de l'entreprise et peux administrer un programme de fournisseurs certifiés lors de l'inspection afin d'assurer la rentabilité.
Surveiller les pièces, de l'acquisition tout au long du cycle de fabrication, et communiquer et résoudre les problèmes liés aux fournisseurs au fur et à mesure qu'ils se produisent.
Soutenir toutes les activités de modification technique associées aux composants achetés auprès des fournisseurs.
Prend en charge la sélection et l'évaluation des fournisseurs, les audits, la liste des fournisseurs approuvés, la segmentation des fournisseurs, les ajouts ou les modifications.
Évalue les fonctions internes des fournisseurs afin d'évaluer leur performance globale et fournit une rétroaction sur l'évaluation de leurs activités.
CAPA de processus et non-conformités associées aux fournisseurs
Surveille et communique les données de performance et de performance des fournisseurs.
Diriger les projets liés aux fournisseurs afin de mettre en œuvre des stratégies visant à stimuler la qualité des produits et l'amélioration continue, tout en veillant à ce que les produits et les composants achetés soient fabriqués et qualifiés conformément aux normes applicables de l'industrie, aux exigences réglementaires et aux exigences des clients.
Fournir un soutien à la qualité des fournisseurs avant la mise en marché pour le développement de nouveaux produits.
Si nécessaire, collaborer avec les ingénieurs des composants pour développer et mettre en œuvre la stratégie d'échantillonnage d'acceptation du produit, la coordination de la liste des fournisseurs approuvés, le déploiement de la qualité appartenant au fournisseur et les plans de contrôle pour les nouveaux produits.
Définir les exigences en matière d'inspection à la réception et la validation des méthodes d'essai associées pour toutes les méthodes d'essai internes de Medtronic.
Disponible à voyager - à 10 %, y compris à l'international (principalement, mais sans s'y limiter, aux États-Unis)
Compétences Requises:
Diplôme de baccalauréat avec 4+ années d'expérience pertinente ou maîtrise avec 2+ années d'expérience pertinente ou doctorat avec 0 année d'expérience pertinente.
Parfaitement bilingue – français et anglais (écrit et oral) – indiqué sur le CV.
Atouts:
Expertise en méthodes Lean et Six Sigma.
Connaissance de ERP/MRP ; expérience avec SAP est un plus.
Maitrise des normes ISO (ISO 13485/FDA 21CFR820 fortement souhaitée).
Maîtrise avancée et connaissance des méthodes d'analyse statistique des données et des outils statistiques associés.
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life:
Maintain continuity of supply components purchased from suppliers while ensuring quality parts, materials, and services.
Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
Monitors parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
Support all engineering change activities associated with components purchased from suppliers.
Supports supplier selection/ evaluation, audits, Approved Supplier List, supplier segmentation, additions or modifications.
Evaluates suppliers' internal functions to assess their overall performance and provides feedback on assessment of their operation.
Process CAPAs and Nonconformances associated with suppliers
Monitors and reports supplier performance / scorecard data.
Lead supplier related projects to implement strategies for driving product quality and continuous improvement, while ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory and customer requirements.
May provide support to Pre-Market Supplier Quality for New Product Development.
If needed, collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods
Available to travel - up to10% including internationally (mostly, but not limited to, USA)
Must Have
Bachelor's degree with 4+ years of relevant experience or Master's degree with 2+ years relevant experience or PhD with 0 years relevant experience.
Fully Bilingual - French and English (written and oral) - indicated on resume
Nice to Have:
Expertise in Lean Six Sigma.
Knowledge of ERP/ MRP; Experience with SAP is a plus
Familiar with ISO standards (ISO 13485/ FDA 21CFR820 is a strong plus)
Advanced use and knowledge of statistical data analysis methods and related statistical tools
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here
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