Associate Compliance and Audit Specialist - Nightshift (12 months Contract)
Associate Compliance and Audit Specialist - Nightshift (12 months Contract)
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1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
You will be responsible for supporting the scoping of Field Corrective Actions (FCAs) globally. Job duties specifically include ensuring robust FCA communication (1st and 2nd Attempts for Digital and/or Physical mailings Kaiser Notification Distributor Notification and VA Notifications). This position involves coordination with a diverse group of people across Medtronic. The individual for this role will need to work independently and as a team player with the ability to use sound judgement and work through ambiguous situations utilizing peers and leadership for assistance as appropriate.Responsibilities may include the following and other duties may be assigned:
Manage and execute 1st and 2nd attempt FCA communications for Neuroscience Medical Surgical and Cardiovascular portfolios with focus on physical and digital mailings in compliance with regulatory requirements.
Ensure FCA documents and records are maintained with accuracy and in compliance with good documentation practices and record retention requirements.
Communicate primarily and frequently with internal contacts. Contact others to share information status needs and issues in order to inform gain input and support decision-making.
Track document and report mailing outcomes to support audit readiness and ensure closure of communication within defined timelines
Support continuous improvement projects to increase effectiveness efficiency and compliance.
Required Knowledge and Experience:
Requires a BachelorsDegree with 2-3 years of work experience in Quality or regulated industry
Quality management or document control experience
Excellent written and verbal communication abilities.
Experience with Good Documentation Practices
Excellent knowledge of Excel
Detail oriented and an agile learner
Experience working with large sets of data
Experience with FDA regulatory medical device requirements 21CFR Part 806 Part 7; ISO 13485 Medical Device Directive
Capable of effectively managing multiple demands from a variety of sources
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 95000 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
Required Experience:
IC
Employment Type
Full-Time
