Quality Systems Manager - Training at Medtronic

Los Angeles, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiabetesIndustries

Requirements

Bachelor’s degree
5+ years of work experience in Quality Management setting in a regulated industry OR Advanced Degree with 3+ years of work experience in Quality Management in a regulated industry
(Nice to Have) 10+ years of work experience in Quality Management setting in a regulated industry
(Nice to Have) Capable of effectively managing multiple demands from a variety of sources
(Nice to Have) Strong expertise with managing complex situations, comfortable escalating issues and operating in grey area
(Nice to Have) Excellent written and verbal communication abilities
(Nice to Have) Working knowledge in the medical device industry, including working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc
(Nice to Have) Experience supporting continuous improvement projects

Responsibilities

Lead the training program and strategy for the Medtronic Diabetes business
Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
Develop strategy and lead governance for training systems and processes
Prepare reports and/or necessary documentation and provide to applicable stakeholders, both internal and external
Provide direction for how laws, regulations, and standards influence training content
Define training standards to meet the needs of new and changing regulations
Serve as training process owner and as subject matter expert for internal and external audits
Manage internal team responsibilities as assigned
Maintain current knowledge of laws, regulations, and industry guidance that impact the company's compliance program
Lead process improvement initiatives
Facilitate uniform training standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally
Ensure the quality assurance programs and policies are maintained and modified regularly

Skills

Key technologies and capabilities for this role

Quality SystemsTraining ProgramsProcess ManagementProject ManagementComplianceQuality ProgramsRegulatory Standards

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This position is expected to be onsite, with the possibility to be at a hybrid capacity requiring 3 days in the office and 2 days working remotely.

What is the salary range for this role?

This information is not specified in the job description.

What skills and experience are required for the Quality Systems Manager - Training role?

The role requires practical knowledge in leading and managing processes, projects, and tactics, advanced knowledge in a specific technical or professional discipline, expertise in interpreting policies and regulations, and skills in developing training strategies and leading process improvements.

What is the company culture like at Medtronic's Diabetes business?

The culture emphasizes leading with purpose, exploration, innovation, championing healthcare access and equity, and operating with greater speed and agility following the planned separation of the Diabetes division to drive meaningful innovation and enhance patient care.

What makes a strong candidate for this Quality Systems Manager position?

Strong candidates will have advanced knowledge in quality systems or a related discipline, experience leading training programs and strategies, expertise in regulatory compliance, and the ability to manage process improvements and audits.

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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