At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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 companys quality mission globally.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 2 years of relevant experience OR Masters 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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.