Medtronic
Principal Quality Systems Business Analyst
Medtronic, Los Angeles, California, United States, 90079
Overview
Principal Quality Systems Business Analyst for Medtronic. This role involves leading quality management system (QMS) initiatives across the Diabetes quality function and technology teams to deliver scalable, flexible QMS globally. The position supports compliance with FDA, ISO, and other applicable standards by monitoring, analyzing, and improving quality processes through technology and data tools, driving continuous improvement across the organization. Responsibilities
Maintain and support the company’s electronic quality management system (eQMS). Monitor and analyze quality system metrics, identifying trends and opportunities for improvement. Assist with management of quality system processes, including CAPA, complaints, nonconformances, internal audits, training, and document control. Generate reports and dashboards to support compliance monitoring and management reviews. Ensure timely and compliant documentation and record-keeping in accordance with FDA and ISO requirements. Participate in internal and external audits, providing data and system support. Collaborate with cross-functional teams to support quality initiatives and continuous improvement projects. Support change management and system updates to maintain compliance and usability. Minimum Requirements
Requires 7+ years of experience with a Bachelor’s Degree or 5+ years of experience with an advanced degree or 12+ years of experience with a High School Diploma or equivalent. Nice To Haves
Experience with Veeva, TrackWise, SmartSolve, SAP QM, or other eQMS platforms Medical Device experience IT/Digital Technology expertise Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. The base salary range for U.S. locations (excludes PR and certain CA locations) is typically $112,800.00 – $169,200.00. This position is eligible for the Medtronic Incentive Plan (MIP). Detailed benefits information is available in the linked materials. Some benefits may vary by location. Regular employees are those who are not temporary; temporary employees may be eligible for paid sick time as required by law. Details vary by location. About Medtronic
Medtronic leads global healthcare technology and aims to alleviate pain, restore health, and extend life. We are engineers at heart—solving real problems for real people. We are committed to diversity and inclusion. 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, or veteran status. Reasonable accommodations are provided for qualified individuals with disabilities. Seniority level
Mid-Senior level Employment type
Full-time Job function
Business Development and Sales Industries
Medical Equipment Manufacturing Hospitals and Health Care Pharmaceutical Manufacturing
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Principal Quality Systems Business Analyst for Medtronic. This role involves leading quality management system (QMS) initiatives across the Diabetes quality function and technology teams to deliver scalable, flexible QMS globally. The position supports compliance with FDA, ISO, and other applicable standards by monitoring, analyzing, and improving quality processes through technology and data tools, driving continuous improvement across the organization. Responsibilities
Maintain and support the company’s electronic quality management system (eQMS). Monitor and analyze quality system metrics, identifying trends and opportunities for improvement. Assist with management of quality system processes, including CAPA, complaints, nonconformances, internal audits, training, and document control. Generate reports and dashboards to support compliance monitoring and management reviews. Ensure timely and compliant documentation and record-keeping in accordance with FDA and ISO requirements. Participate in internal and external audits, providing data and system support. Collaborate with cross-functional teams to support quality initiatives and continuous improvement projects. Support change management and system updates to maintain compliance and usability. Minimum Requirements
Requires 7+ years of experience with a Bachelor’s Degree or 5+ years of experience with an advanced degree or 12+ years of experience with a High School Diploma or equivalent. Nice To Haves
Experience with Veeva, TrackWise, SmartSolve, SAP QM, or other eQMS platforms Medical Device experience IT/Digital Technology expertise Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. The base salary range for U.S. locations (excludes PR and certain CA locations) is typically $112,800.00 – $169,200.00. This position is eligible for the Medtronic Incentive Plan (MIP). Detailed benefits information is available in the linked materials. Some benefits may vary by location. Regular employees are those who are not temporary; temporary employees may be eligible for paid sick time as required by law. Details vary by location. About Medtronic
Medtronic leads global healthcare technology and aims to alleviate pain, restore health, and extend life. We are engineers at heart—solving real problems for real people. We are committed to diversity and inclusion. 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, or veteran status. Reasonable accommodations are provided for qualified individuals with disabilities. Seniority level
Mid-Senior level Employment type
Full-time Job function
Business Development and Sales Industries
Medical Equipment Manufacturing Hospitals and Health Care Pharmaceutical Manufacturing
#J-18808-Ljbffr