Configuration Assurance Administrator at Medtronic

Boulder, Colorado, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, ManufacturingIndustries

Requirements

High School Diploma or equivalent with 2+ years of experience
Advanced Degree with 0 years of experience
Change Control experience (nice to have)
Validation experience / knowledge (IQ, OQ, TMV, PQ) (nice to have)
Experience in medical device manufacturing, regulatory environments, or highly regulated industries (nice to have)
Experience working in a fast-paced manufacturing environment (nice to have)

Responsibilities

Serves as the primary contact for processing validation change orders, ensuring compliance with validation documentation standards and Good Manufacturing Practices (GMP)
Manages and processes additional change orders as needed
Organizes and compiles documentation for Corrective Action Board review, and collects and reports relevant data
Processes change orders, ranging from simple-to-complex, for the creation and revision of product, process, and system designs
Reviews and analyzes change data provided by all functions and facilitates coordination of changes with applicable stakeholders, including engineering, quality, manufacturing, and operations
Manages the change order process and prepares for change approvals by stakeholders
Prepares change management status reports
Ensures procedural requirements are implemented while maintaining compliance to applicable policies, procedures, regulations, and standards

Skills

Key technologies and capabilities for this role

GMPChange OrdersValidation DocumentationCorrective ActionStakeholder CoordinationEngineeringQualityManufacturingOperations

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is a fully 100% on-site position located at the Boulder, CO Manufacturing site, requiring a minimum of 5 days a week onsite.

What are the must-have skills for this role?

Functional skills include Change Control, Document Management, Compliance, Product Lifecycle Management, and Electronic Document Management Systems. Additional skills are Detail Oriented, Cross-Functional Collaboration, Customer Service, Process Improvement, Communication, and Problem Solving.

What is the company culture like at Medtronic?

The Medtronic Mindset emphasizes acting boldly, competing to win, moving with speed and decisiveness, fostering belonging, and delivering results the right way. It promotes a culture of professional growth, cross-functional collaboration, and putting patients first.

What is the salary for this position?

This information is not specified in the job description.

What should I include in my application to be considered?

Ensure the minimum requirements are evident in your application, as they are must-haves to be considered for the role.

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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