MDR Vigilance Specialist II

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

Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.

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

• 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 all on complaints.

• Determines Reportability of complaints 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 - MITG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.

• Interacts with groups external to Medtronic - MITG, such as customers, vendors, health care professional

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: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Minimum Qualifications

• Bachelor degree; Engineering or Science degrees preferred (e.g. SW,EE, ME, Biomedical Engineering)

• 4 to 8 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.  

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

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

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.

Learn more about our business, mission, and our commitment to diversity here