Supplied Quality Engineer II

2 days ago


Penang, Malaysia Medtronic Full time $120,000 - $180,000 per year

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 LifeMedtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value – and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Responsibilities may include the following and other duties may be assigned:

  • Manages strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) at Medtronic, with accountability for product and process changes, performance oversight, and continuous improvement initiatives.

  • Maintains quality controls and drives improvements in finished medical devices and components, working within supplier quality systems to ensure compliance and reliability.

  • Ensures suppliers consistently deliver high-quality parts, materials, and services, and qualifies them according to company standards; may also oversee a Certified Supplier Program to optimize cost-effectiveness.

  • Monitors components throughout the manufacturing cycle, proactively addressing and resolving supplier-related issues as they arise.

  • Develops and prioritizes supplier audit schedules to ensure adherence to Good Manufacturing Practices (GMP) and quality standards.

  • Evaluates suppliers' internal operations to assess overall performance and provides actionable feedback for improvement.

  • Supports Pre-Market Supplier Quality by partnering with New Product Development (NPD), Component Engineering, and Post-Market Supplier Quality teams to ensure defect prevention and delivery of reliable, high-quality products.

  • Provides technical guidance and quality compliance throughout the NPD lifecycle, including defining receiving inspection requirements, validating test methods, and collaborating on sampling strategies, supplier quality ownership, and control plans.

  

Required Knowledge and Experience:

  • Bachelor's degree in Business, Engineering, or Medical Science.

  • Minimum of 3 years of relevant experience in electromechanical systems, embedded software, or a related role.

  • Experience in the medical device industry is preferred.

  • Proficient in troubleshooting complex capital medical devices involving mechanical, electrical, and software components.

  • Strong hands-on experience with schematics, system diagnostics, and root cause analysis.

  • Familiarity with medical device quality standards (ISO 13485, IEC 60601, IEC and structured problem-solving in a regulated environment. Knowledgeable in computer applications, including the MS Office suite.

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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