Quality Engineer II - Carrie Green

CHN China (Mainland); Pointe-Claire; On-site; CAD 70,000 - 90,000; Full time

Job summary

Une entreprise leader dans la technologie médicale recherche un Ingénieur Qualité II pour rejoindre son équipe à Pointe-Claire. Le candidat idéal possédera des compétences en gestion de projet et en fabrication médicale, et sera responsable du maintien des normes de qualité. Rejoignez une équipe engagée à améliorer la santé globale avec des solutions innovantes.

Benefits

Assurance santé

Plan d'incitation à court terme

Horaire de travail flexible

Qualifications

• Baccalauréat ou diplôme d'études supérieures en ingénierie.
• Minimum de 2 ans d'expérience en ingénierie qualité requise.
• Expérience en fabrication médicale et bonnes pratiques documentaires.

Responsibilities

• Élaborer et maintenir des normes et protocoles de qualité.
• Collaborer avec les fonctions d'ingénierie et de fabrication.
• Conception de méthodes pour inspection et test des produits.

Skills

Gestion de projet

CAPA

Lean Manufacturing

DMAIC

Education

Baccalauréat en ingénierie

Tools

SAP ERP

Minitab

Job description

Quality Engineer II - Carrie Green page is loaded

Quality Engineer II - Carrie Green

Apply remote type Flexible Work Arrangement locations Pointe-Claire, Quebec, Canada time type Full time posted on Posted Yesterday time left to apply End Date: June 25, 2025 (12 days left to apply) job requisition id R33967

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

Dans ce rôle passionnant d'Ingénieur Qualité II, vous serez responsable de la qualité en fabrication et ferez partie de l’équipe qualité de Montréal. Ce poste implique de soutenir et de superviser divers produits liés aux Solutions d’Ablation Cardiaque (CAS).

Joignez-vous à une équipe diversifiée d'ingénieurs qui apportent leur vision du monde, leurs antécédents uniques et leurs expériences de vie individuelles chaque jour au travail. Ce n'est pas un hasard - nous travaillons dur pour cultiver une main-d'œuvre qui reflète nos patients et nos partenaires. Nous pensons que c'est la seule façon de faire progresser les soins de santé et de rester un leader mondial en matière de technologie et de solutions médicales.

Lieu de travail : Pointe-Claire. Poste sur site .

Une journée dans la vie

Les responsabilités peuvent comprendre les éléments suivants et d'autres tâches peuvent être assignées.

• Élaborer, modifier, appliquer et maintenir des normes et des protocoles de qualité pour la transformation des matériaux en produits finis ou partiellement finis.

• Collaborer avec les fonctions d'ingénierie et de fabrication pour s'assurer que les normes de qualité sont en place.

• Conçoit et met en œuvre des méthodes et des procédures d'inspection, d'essai et d'évaluation de la précision et de l'exactitude des produits et de l'équipement de production.

• Conçoit ou spécifie des mécanismes et équipements d'inspection et d'essai, effectue des tests d'assurance qualité et réalise des analyses statistiques afin d'évaluer le coût et de déterminer la responsabilité des produits ou matériaux qui ne répondent pas aux normes et spécifications requises.

• Diriger et/ou participer à des équipes d'action corrective/préventive pour résoudre les problèmes liés à la production et aux clients. Il veille à ce que les mesures correctives répondent à des normes de fiabilité acceptables et à ce que la documentation soit conforme aux exigences.

• Peut se spécialiser dans les domaines de la conception, des matériaux entrants, du contrôle de la production, de l'évaluation et de la fiabilité des produits, du contrôle des stocks et/ou de la recherche et du développement dans la mesure où ils s'appliquent à la qualité des produits ou des processus.

• Effectuer ou fournir des conseils à l'ingénierie de fabrication sur la validation efficace des processus, la validation des méthodes d'essai et les enquêtes sur les matériaux non conformes.

• Veiller à ce que les dossiers de qualité locaux relatifs aux dispositifs finis, tels que les dossiers de référence des dispositifs, les dossiers historiques des dispositifs, les plans de validation de référence, les Modes de défaillance, effets et analyse de criticité ( FMECAs ) de processus, etc. soient exacts, à jour et conformes à la réglementation.

• Disposition de tous les matériaux/composants rejetés pour cause de non-conformité en menant une enquête approfondie sur les causes et en déterminant des mesures correctives efficaces.

• Identifie et met en œuvre des idées d'amélioration continue sur la base des observations faites au cours des activités quotidiennes.

• Examine r et évalue r les problèmes liés aux produits sur le terrain.

Doit posséder : Exigences minimales

Pour être pris en considération pour ce poste, veuillez-vous assurer que les exigences minimales sont évidentes dans votre profil de candidat.

• Baccalauréat en ingénierie ou dans un domaine technique avec un minimum de 2 ans d'expérience en ingénierie de la qualité, ou diplôme d'études supérieures avec 0 ans d'expérience.

Ce qui est préférable de savoir

• Gestion de projet

• Expérience en matière d'actions correctives - en particulier les actions correctives et préventives ( CAPA s )

• Expérience d e la production au plus juste ( Lean Manufacturing ) , expérience de la résolution de problèmes Définir , mesurer , analyser , améliorer et contrôler ( DMAIC ) .

• Expérience de la fabrication médicale et des pratiques de bonnes pratiques de documentation (GDP)

• Expérience des audits internes et externes

• Expérience des systèmes d'exploitation de cellules (COS)

• SAP ERP, logiciel Agile
• Logiciel Minitab

• Expérience préalable dans la fabrication de cathéters

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In this exciting Quality Engineer II role, you will be responsible for manufacturing quality and will be part of the Montreal quality team. This role involves supporting and overseeing various products supporting Cardiac Ablation Solutions (CAS) .

Join a diverse team of engineers who bring their worldview, unique backgrounds and individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to advance healthcare and remain a global leader in medical technology and solutions.

Workplace: Pointe-Claire. On-site position.

Responsibilities include the following and other duties may be assigned.

• Develop, modify , implement and maintain quality standards and protocols for the transformation of materials into finished or partially finished products.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and test mechanisms and equipment, conducts quality assurance tests and performs statistical analyses to evaluate the cost and determine the responsibility of products or materials that do not meet required standards and specifications.
• Leads and/or participates in corrective/preventive action teams to resolve production and customer issues. Ensures that corrective actions meet acceptable reliability standards and that documentation complies with requirements.
• May specialize in the areas of design, incoming materials, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Perform or provide advice to Manufacturing Engineering on effective process validation, test method validation and investigation of non-conforming materials.
• Ensure that local quality records relating to finished devices, such as device reference records, device history records, reference validation plans, process Failure Modes, Effects and Criticality Analysis (FMECAs), etc. are accurate , up to date and compliant with regulations.
• Disposes of all materials/components rejected for non-conformance by thoroughly investigating causes and determining effective corrective actions.
• Identifies and implements continuous improvement ideas based on observations made during daily activities.
• Investigates and evaluates product problems in the field .

Minimum Qualifications:

To be considered for this position, please ensure that the minimum requirements are evident in your candidate profile.

• Bachelor's degree in engineering or technical field with a minimum of 2 years' experience in quality engineering, or advanced degree with 0 years' experience.

Preferred Qualifications:

• Project management skills
• Experience in corrective actions - especially corrective and preventive actions (CAPAs)
• Lean manufacturing experience, Define, Measure, Analyze, Improve and Control (DMAIC) problem-solving experience
• Experience of medical manufacturing and Good Documentation Practices (GDP)
• Experience of internal and external audits
• Experience of cell operating systems (COS)
• SAP ERP, Agile software
• Minitab software
• Previous experience in catheter manufacturing

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

Who We Are

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.

What We Do

We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will…

Build a better future, amplifying your impact on the causes that matter to you and the world

Grow a career reflective of your passion and abilities

Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

How We Are Different

These commitments set our team apart from the rest:

Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

For updates on job applications, please go to the candidate login page and sign in to check your application status.