Principal Quality Systems Business Analyst at Medtronic

Northridge, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

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

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 the 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

Skills

Key technologies and capabilities for this role

eQMSQMSCAPAFDAISOMetrics AnalysisDashboardsData AnalysisCompliance MonitoringDocument ControlInternal AuditsNonconformancesComplaints Management

Questions & Answers

Common questions about this position

What experience level is required for the Principal Quality Systems Business Analyst role?

The role requires 7+ years of experience with a Bachelor’s Degree, 5+ years with an advanced degree, or 12+ years with a High School Diploma or equivalent.

What are some nice-to-have skills or experiences for this position?

Nice-to-haves include experience with Veeva, TrackWise, SmartSolve, SAP QM, or other eQMS platforms, medical device experience, and IT/Digital Technology expertise.

Is this a remote position or does it require office presence?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does Medtronic's Diabetes business look like for this role?

This role offers an exciting opportunity in Medtronic's Diabetes business, which is planning to separate into its own entity to enable greater speed, agility, increased investments, and enhanced innovation in patient care.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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