Quality Engineer II

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 LifeAs 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 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 locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

 

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

 

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

 

Further details are available at the link below:

Medtronic benefits and compensation plans

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.

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.