Senior Quality Engineer
Medtronic
Summary
The Senior Quality Engineer serves as a quality representative supporting manufacturing operations, process improvements, product quality initiatives, and regulatory compliance activities. This role partners across functions to drive product quality, ensure process effectiveness, investigate quality issues, and support continuous improvement efforts throughout the product lifecycle.
Job description
Primary Responsibilities
- Lead quality engineering activities supporting manufacturing processes and product quality performance.
- Partner with Manufacturing, Operations, and Research and Development teams to implement process improvements and quality controls.
- Analyze quality data, identify trends, and drive corrective and preventive actions to address nonconformances.
- Support root cause investigations and resolution of product, process, and supplier quality issues.
- Develop, review, and approve quality documentation, procedures, validation protocols, and engineering changes.
- Ensure compliance with applicable Quality Management System requirements and regulatory standards.
- Participate in risk management activities and support product and process risk assessments.
- Drive continuous improvement initiatives that enhance product quality, process capability, and operational performance.
Required Qualifications
- Bachelor's degree and 4+ years of quality engineering, manufacturing, or regulated industry experience OR an advanced degree and 2+ years of quality engineering, manufacturing, or regulated industry experience.
- Experience applying quality tools for root cause analysis, corrective actions, and process improvement.
- Experience supporting quality systems within a regulated environment.
- Experience analyzing quality data and developing effective quality solutions.
- Working knowledge of process validation, risk management, or quality engineering methodologies.
Preferred Qualifications
- Experience in medical device manufacturing.
- Knowledge of United States Food and Drug Administration regulations, ISO 13485, and Quality System requirements.
- Experience with nonconformance, corrective and preventive action, and change control processes.
- Experience supporting product transfers, process validations, or manufacturing process improvements.
- Certification as a Quality Engineer or related quality certification through the American Society for Quality.
Requirements
- Bachelor's degree and 4+ years of quality engineering, manufacturing, or regulated industry experience OR an advanced degree and 2+ years of quality engineering, manufacturing, or regulated industry experience
- Experience applying quality tools for root cause analysis, corrective actions, and process improvement
- Experience supporting quality systems within a regulated environment
- Experience analyzing quality data and developing effective quality solutions
- Working knowledge of process validation, risk management, or quality engineering methodologies
- Experience in medical device manufacturing
- Knowledge of United States Food and Drug Administration regulations, ISO 13485, and Quality System requirements
- Experience with nonconformance, corrective and preventive action, and change control processes
- Experience supporting product transfers, process validations, or manufacturing process improvements
- Certification as a Quality Engineer or related quality certification through the American Society for Quality
Benefits
- Health, Dental & Vision
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Incentive Plans
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.