Senior Change Control Administrator

Quality             ·              Menlo Park, California, United States                ·                Full time

Senior Change Control Administrator

Menlo Park, California, United States

ID: 23000BDW

Job Description

Min Salary USD: 88,400

Max Salary USD: 132,600

Travel: No

Careers that Change Lives

Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimulation (DBS) system to treat movement disorders and the first implantable drug pump to deliver medication directly to the intrathecal space of the spine. More than 40 years later, we continue to innovate, constantly challenging ourselves to disrupt the markets we created. We advance science by thinking and acting boldly, bringing together the right people with the right breadth of expertise to engineer groundbreaking therapies and technologies.

The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients, delivering solutions that improve lives as we embody a culture of accountability and trust.

Over the past 20 years, we have become the global market leader in three key segments – image-guided surgery, intraoperative nerve monitoring, and powered surgical instruments. We continue to launch valuable ENT solutions in these areas as well as tissue health and balloon sinus dilation.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Analyzes proposed changes of product design to determine effect on overall product and system.
• Coordinates modification records for management control.
• Establishes change orders and prepares for change authorization and documentation by company and subcontractor.
• Prepares reports of change effect on overall product.
• Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, support, manufacturing, and engineering data control activities.
• Ensures that customer requirements are implemented and reviews change accounting activity to ensure compliance with configuration management policies.
• Publish weekly change orders status reports and work with cross functional management on prioritization of Change Orders.
• Analyze data, conduct continual improvement projects, create solutions, and work on related CAPA initiatives.
• Analyze processes, procedures, data, risks, and work structure to create solutions for overall efficiency improvements.
• Update Document Control and Training systems’ related procedures as needed.
• Provide global search reports in EQMS & LMS as requested.
• Perform records archival as assigned.

Must Have:

Minimum Requirements

• Requires 4+ years of experience with a High School Diploma or equivalent or Advanced Degree with a minimum of 2 years of relevant experience

Nice to Have

• Medical Device or Pharma Document Control Experience
• Leading & Managing Projects
• Delivering Training Classes for Document Control Related Systems
• Knowledge of Configuration Management Principles (Would be a plus)

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. 

Committing to our employees’ lives is at our values’ core. We recognize their contributions. They share in the success they help to create.  We offer many benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

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