Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

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Job Responsibilities
Evaluates incoming complaint information and maintains the record in the electronic database. Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data on all complaints. Determines Reportability of complaints and submits Regulatory Reports to Government Agencies. Identify and document appropriate complaint categories to assure trend accuracy within the complaint database. Writes investigation summaries based on technical product analysis information provided; Ensures record documentation is maintained in a constant state of audit readiness per internal policies. Liaison with groups who perform additional investigation and who prepare written record of investigation. Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing. Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations. Reviews and interprets risk management documentation as it applies to the complaint event. Interacts with multiple departments within Medtronic - RTG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering. Interacts with groups external to Medtronic - RTG, such as customers, vendors, health care professional


Minimum Qualifications
Bachelor degree; Engineering or Science degrees preferred (e.g. ECE, Biomedical Engineering, ME) 0-4 years quality assurance or regulatory experience in medical or pharmaceutical industry. Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis Strong typing skills and ability to write business documents with minimal supervision. Strong verbal and written communication skills and ability to work in a team oriented environment Ability to multitask. Ability to understand the functionality / intended use of complex medical devices. Minimum travel may be required


Nice to Haves
Knowledge of medical devices, their development and quality control. Knowledge of FDA, MEDDEV, Canadian Regulations. Technical Writing experience.
Responsibilities may include the following and other duties may be assigned.


This is a temporary position. Responsible for performing and supporting research for teams operating within a service group, or product group and/ or project group. Assists with the development, monitoring, coordination and implementation of technical projects as assigned. Provides analysis, reporting and internal communication services with team members. Develops knowledge of industry and organizational processes.

SPECIALIST CAREER STREAM:

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy:

Entry-level individual contributor on a project or work team.


Works with close supervision.

Organizational Impact:

Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity:

Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.


Makes minor changes in systems and processes to solve problems .

Communication and Influence:

Communicates primarily with internal contacts within immediate group.


Contacts others to gather, confirm and convey information.

Leadership and Talent Management:

N / A - job at this level is focused on self-development .

Required Knowledge and Experience:

Requires broad theoretical job knowledge typically obtained through advanced education.


Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A), 0 years of experience required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

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Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

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We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.


Our Mission -- to alleviate pain, restore health, and extend life -- unites a global team of 95,000+ passionate people.


We are engineers at heart-- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.