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Quality Engineer II - Post-Market Surveillance

Medtronic
United Statesfull_timeVerifiedPosted 5 Nov 2025
💰 $115,200/yr

About the role

We anticipate the application window for this opening will close on - 12 Nov 2025


 

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

As a Quality Engineer II, where you'll play a pivotal role in driving quality excellence and continuous improvement. Reporting to the Post-Market Quality Manager, you'll lead trend analysis of complaints and quality data, conduct Product hold, field action activities, and manage quality improvement projects. Based in Colorado, this position offers the opportunity to work in a dynamic, innovative-driven environment where your analytical skills will directly impact product quality and patient safety.

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

  • 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.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of post-market surveillance of commercial products,
  • design, product evaluation and reliability, and/or research and development as they apply to product or process quality.

Must Have: Minimum Requirements

  • Bachelor’s degree required
  • Minimum of 2 years of relevant experience, OR Master’s degree with a minimum of 0 years of relevant experience

Nice to Have
 

  • Experience in quality data analysis and trending in medical device industry
  • Strong statistical analysis skills and proficiency with tools like Minitab, JMP, or Excel advanced functions
  • Knowledge of medical device regulations: FDA 21 CFR Part 820, ISO 13485, MDR/IVDR
  • Experience with CAPA processes and root cause analysis methodologies (5-Why, Fishbone, 8D)
  • Project management experience with quality improvement initiatives
  • Experience with quality management software (TrackWise, GCH, or similar)
  • Experience supporting or leading internal/external audits (FDA, ISO, Notified Body)
  • Excellent analytical and problem-solving skills with attention to detail
  • Ability to lead cross-functional teams and manage multiple projects simultaneously
  • Self-motivated with ability to work independently and drive initiatives to completion.

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. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

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.
 

Salary ranges for U.S (excl. PR) locations (USD):$76,800.00 - $115,200.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locat

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Company

Medtronic

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