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Full-Time

Quality Engineer II

Posted on 10/22/2024

Medtronic

Medtronic

5,001-10,000 employees

Develops and manufactures medical devices and therapies

Biotechnology
Healthcare

Junior, Mid

Pointe-Claire, QC, Canada

Part of the Montreal Quality team.

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Minitab
Agile
SAP Products
Requirements
  • Bachelor’s degree in Engineering or technical field with minimum of 2 years of Quality Engineering experience, or advanced degree with 0 years of experience.
  • Corrective Action experience – specifically CAPA
  • Experience with Lean Manufacturing, DMAIC problem solving experience.
  • Experience in Medical manufacturing and GDP practices
  • Experience with internal and external audits
  • SAP ERP, Agile software
  • Minitab software
  • Prior experience with catheter manufacturing
Responsibilities
  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Leads and/or participates in corrective/preventive action teams in resolving production and customer issues. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
  • Performs or provides guidance to Manufacturing Engineering on effective Process Validation, Test Method Validation and nonconforming material investigations.
  • Ensures that local quality records supporting finished devices such as Device Master Records, Device History Records, Master Validation Plans, Process FMECAs, etc. are accurate, current, and compliant to regulations.
  • Dispositions any materials / components that are rejected for non-conformance with thorough investigations of the cause and determination of effective corrective actions.
  • Identifies and implements continuous improvement ideas based on observations during day-to-day activities.
  • Investigates and evaluates product field problems.

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals and healthcare professionals around the world. Medtronic stands out from competitors by not only focusing on product development but also offering comprehensive services such as training for healthcare providers and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through their advanced medical solutions.

Company Stage

IPO

Total Funding

$3.2M

Headquarters

Fridley, Minnesota

Founded

N/A

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
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Simplify's Take

What believers are saying

  • Medtronic's recent product innovations, such as the InterStim Micro Neurostimulator and remote monitoring systems, highlight its commitment to advancing medical technology.
  • The company's expansion in Asia, including the launch of the Robotics Experience Studio, indicates strong growth potential in emerging markets.
  • Strategic partnerships and acquisitions, like the collaboration with Ramsay Health Care and the acquisition of Paceart Optima, enhance Medtronic's capabilities and market position.

What critics are saying

  • The highly competitive medical technology market requires Medtronic to continuously innovate to maintain its leadership position.
  • Integration challenges from acquisitions and partnerships could potentially disrupt operations and delay product development.

What makes Medtronic unique

  • Medtronic's extensive R&D investment enables continuous innovation in medical technology, setting it apart from competitors who may not have the same level of resources.
  • The company's global reach, operating in over 150 countries, provides a significant advantage in market penetration and customer base.
  • Medtronic's comprehensive suite of products and services, including training and patient management programs, offers a holistic approach to healthcare that many competitors lack.

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