Senior Quality Engineer - 2nd shift
Medtronic
Summary
The Operations Quality team partners with manufacturing, engineering, and technical functions to ensure compliance, process capability, product quality, and continuous improvement across manufacturing operations. As a Senior Quality Engineer, you will provide quality engineering support for manufacturing operations with a primary focus on process validation and quality system execution. This role partners closely with engineering and manufacturing teams to ensure compliant, effective, and sustainable manufacturing processes while driving product quality, process reliability, and regulatory compliance within a highly regulated medical device environment. This position is based at our manufacturing facility in West Valley City, Utah, and requires an onsite work schedule of Monday through Thursday, 3:30 p.m. to 2:00 a.m. (second shift).
Job description
Primary Responsibilities
- Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and ongoing process monitoring.
- Partner with manufacturing and engineering teams to develop, implement, and maintain quality standards, controls, and manufacturing process requirements.
- Drive root cause investigations, corrective and preventive actions (CAPA), and nonconforming material (NCMR) activities to resolve quality issues and prevent recurrence.
- Analyze quality and process performance data using statistical methods to support risk-based decision making and continuous improvement initiatives.
- Develop and implement inspection, testing, and evaluation methods to verify product quality and manufacturing process capability.
- Support qualification and validation of manufacturing equipment, processes, and test methods.
- Ensure quality documentation, validation records, and manufacturing practices comply with applicable regulatory and quality system requirements.
- Mentor quality and engineering colleagues and provide technical leadership on complex quality and validation projects.
Required Qualifications
- Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience OR Master's degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience OR PhD.
Preferred Qualifications
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related engineering discipline; advanced degree preferred.
- Experience leading process validation activities for complex manufacturing processes in regulated environments.
- Experience with FDA-regulated medical device or pharmaceutical manufacturing.
- Experience using statistical analysis tools such as Minitab to support process improvement and quality decision making.
- Knowledge of Code of Federal Regulations (CFR) requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
- ASQ Certified Quality Engineer (CQE), Lean Six Sigma certification, or similar quality certification.
- 2+ years of experience executing process validation activities across the full validation lifecycle.
Requirements
- Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience OR Master's degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience OR PhD.
- Experience leading process validation activities for complex manufacturing processes in regulated environments.
- Experience with FDA-regulated medical device or pharmaceutical manufacturing.
- Experience using statistical analysis tools such as Minitab to support process improvement and quality decision making.
- Knowledge of Code of Federal Regulations (CFR) requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
- ASQ Certified Quality Engineer (CQE), Lean Six Sigma certification, or similar quality certification.
- 2+ years of experience executing process validation activities across the full validation lifecycle.
Benefits
- Health, Dental & Vision
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- Incentive Plans
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
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.