Quality Systems Manager - Change Control 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

Medical Devices, HealthcareIndustries

Requirements

Baccalaureate degree
Minimum of 5 years relevant experience in Quality Management setting in a regulated industry, or advanced degree with a minimum of 3 years prior relevant experience
Practical knowledge in leading and managing the execution of processes, projects and tactics within one job area
Advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization
Capable of effectively managing multiple demands from a variety of sources
Strong expertise with managing complex situations, comfortable escalating issues and operating in grey area
Excellent written and verbal communication abilities
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
Experience supporting continuous improvement projects
Strong critical thinking and analytical skills

Responsibilities

Provides 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
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
Leads the QMS change control process, including QMS document changes and product related changes in the QMS software
Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
Co-ordinates legal requests in support of government investigations or litigations
Ensures the quality assurance programs and policies are maintained and modified regularly
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally

Skills

Key technologies and capabilities for this role

QMSChange ControlQuality SystemsRegulatory ComplianceProcess AnalysisDiabetes Business

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

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

What experience is required for this role?

A Baccalaureate degree is required with a minimum of 5 years relevant experience in Quality Management in a regulated industry, or an advanced degree with a minimum of 3 years prior relevant experience. Nice to have is 10+ years of work experience in Quality Management in a regulated industry.

What is the salary range for this position?

This information is not specified in the job description.

What is the company culture like at Medtronic?

Medtronic emphasizes a life-long career of exploration and innovation, leading with purpose to champion healthcare access and equity, while breaking down barriers to innovation in a connected, compassionate world. The Diabetes business is separating to promote growth, innovation, speed, and agility with increased investments for patient care impact.

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

Strong candidates will have a Baccalaureate degree with at least 5 years (or 3 with advanced degree) in Quality Management in a regulated industry, ideally 10+ years, plus practical knowledge in leading processes, projects, and tactics.

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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