MDR/Vigilance Specialist/ Pay Rate: $40/hr on W2

Job Title: MDR/Vigilance Specialist

Location: 8200 Coral Sea Street NE Mounds View, MN 55112

Job Description:

Must Have:

• Bachelor's Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field in Engineering and/or Quality

Nice To Have:

• Bachelors or Masters Degree in Mechanical Engineering, or other related engineering degree strongly preferred.
• Experience in medical device design and application of test standards.
• Experience in application statistical methods to design reliability and process capability.
• Certified Quality Engineer, Reliability Engineer, or equivalent desired.
• Strong oral and written communication skills.
• Cross-functionally and an effective team player.
• Excellent presentation skills.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Working knowledge of appropriate industry standards.
• Must be able to work in a team environment and exert influence without alienating others.
• Knowledge/basic understanding of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.

Top 3 skills:

• Complaint handling experience
• Knowledge of IMDRF or complaint coding is a plus
• Project management

Can you please confirm the 3 main responsibilities/day to day activities required for this role:

• Map complaint code to categories
• Update Work Instructions accordingly
• Work with a cross-functional team

Products (if any) will this role support: Cardiovascular Surgery products

Years of experience: 3-5 years

Responsibilities:

• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and followup on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.