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Configuration Assurance Analyst

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Quality
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19000F4G Requisition #
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Configuration Assurance Analyst

Req Number 19000F4G

Northridge, CA

 

Careers That Change Lives

 

In this exciting role as a Configuration Assurance Analyst, within the Quality System department, you will have responsibility for planning and managing the configuration of documentation and parts associated with developing and manufacturing devices throughout the product life cycle. As a Configuration Assurance Analyst, you will assist in and coordinate the creation, approval, and release of documents; drive timely release of documentation according to project schedules through interaction with documentation authors and approvers from many levels of the organization as well as communicate status of documentation and parts configuration to engineers and project managers. You will be responsible for analyzing situations within defined, standard business procedures and practices for finding readily obtainable configuration management solutions to problems of moderate scope. This position will report to the Configuration Assurance Supervisor.

 

DIABETES

Transforming diabetes care together, for greater freedom and better health.

Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

 

Visit www.medtronicdiabetes.com  to see an overview of the products in our Diabetes product portfolio.

 

 

A Day in the Life

 

  • 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.
  • Process change orders in compliance with applicable procedures that support compliance with regulations and standards pertaining to medical device quality system change management.
  • Drive and facilitate in a timely manner the change, approval and release of documentation according to project schedules, including the resolution of resource issues relative to the processing of Engineering Change Requests, Engineering Change Orders, Archive Change Orders, Document Change Requests, Data Change Notifications, Pre-Release Change Orders and Deviations.
  • Provide direction and guidance in the change order process and work with change originators to maintain clear, concise and valid documents throughout.
  • Responsible for ensuring that the best practices of Part/Document Change Management are followed.
  • Monitor parts and documents changes management process effectiveness and contribute to problem solving/continual improvement discussions regarding change control process, including the impact of changes and takes the initiative to recommend process improvements.
  • 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.
Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

 

Bachelor’s degree with 2+ years of experience in quality, configuration assurance and/or document controls/processing, or advanced degree with 0 years of experience in quality, configuration assurance and/or document controls/processing.

      

Nice to Have (Preferred Qualifications)


  • Familiarity with ERP systems, SAP Document Management Systems, PLM systems and/or manufacturing documentation (e.g., BOM, item masters, AGILE etc.).

  • Configuration assurance, managing documentation associated with complex product configurations and/or related experience.

  • Proficient in Microsoft Word, PowerPoint, and Excel.

 
  • Proficient using the following software systems: Agile, SAP and Winshuttle.
  • Certificate in CM2 Configuration Management.
  • Knowledgeable in using Agile PLM Import Tool and competent in Agile searches.
  • Skilled in tasks associated with document handling, archiving and change management.
  • Experience in the manufacture and development of product, preferably medical devices.
  • Experience with and understanding of medical device quality systems.
  • Knowledge of product(s) design and assembly to make informed decisions about configuration management so that the documentation is efficient and complete.
  • Ability to read design and manufacturing drawings and documents.
  • Ability to communicate in writing clearly and concisely, using excellent grammar and sentence structure.
  • Excellent analytical and verbal communication skills.
  • Strong attention to detail and accuracy.
  • Strong time management, organizational, and prioritization skills.
  • Ability to effectively manage multiple projects and priorities.
  • Ability to interface professionally at all levels of the organization.
  • Ability to work in a team environment as well as independently and with minimal supervision.


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 the 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

 
Travel up to 10%.

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