We anticipate the application window for this opening will close on - 17 Oct 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 Quality Systems Manager, you'll lead trend analysis of complaints and quality data, conduct Product hold, filed action activities , and manage quality improvement projects. Based in Colorado, this position offers the opportunity to work in a dynamic, innovation-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.

• Analyzes complaint and quality data trends - Collects, analyzes, and reports trends from complaint data, non-conformances, CAPAs, and production metrics. Identifies patterns and emerging issues to drive proactive preventive actions and support data-driven decision making.
• Drives quality and product improvement projects - Initiates and manages cross-functional improvement initiatives. Implements Lean/Six Sigma methodologies and ensures sustainable quality enhancements throughout the product lifecycle.
• Performs statistical analysis and quality metrics reporting - Conducts statistical analysis to assess process capability, product performance, and compliance trends. Creates dashboards and reports to communicate quality performance to management and stakeholders.
• Executes CAPA activities - Initiates, tracks, and manages Corrective and Preventive Actions (CAPAs) related to quality issues. Verifies effectiveness of corrective actions and ensures proper documentation and closure within established timelines.
• Develops and maintains quality standards and protocols - Creates, updates, and implements quality procedures, work instructions, and inspection protocols for manufacturing processes. Ensures documentation compliance with FDA 21 CFR Part 820, ISO 13485, and MDR requirements.
• Collaborates with engineering and manufacturing functions - Works closely with R&D, Operations, and Production teams to establish quality standards, resolve quality issues, and ensure quality requirements are integrated throughout product development and manufacturing.
• Supports audit and inspection readiness - Prepares quality documentation for regulatory inspections (FDA, Notified Body, ISO) and internal audits. Participates in audit activities and leads resolution of audit findings.
• Ensures documentation compliance - Maintains accurate and complete quality records including test results, inspection data, risk assessments, and improvement project documentation. Ensures all documentation meets regulatory and internal requirements.
• Provides quality oversight for processes - Works directly with operating entities to provide process analysis oversight on a continuing basis to enforce quality requirements and meet regulatory standards.
• Facilitates global quality standards - Supports implementation of uniform quality standards across sites and enables best practice sharing to foster achievement of company's quality mission globally.

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)
• roject 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 n