Quality Complaints Management Specialist - Urgent Need

Duties and Responsibilities

• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine and track product event status
• Affirm timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products
• Write and submit complaint investigation reports into the complaint management system
• Cook up, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information
• Maintain complaint in accordance with regulatory requirements
• Comply with the site Quality System
• Perform other duties as assigned

Knowledge and Skills

• Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry
• Attention to detail is essential
• Able to utilize computers for development of reports and summary of project experience
• Strong proficiency with MS Office tools to include Word, Excel, PowerPoint, and Outlook
• Prior work experience with Trackwise Complaint Handling System preferred
• Prior experience filing eMDRs preferred
• Ability to work on multiple projects with various disciplines are essential
• Ability to multitask in an ever-changing environment
• Position requires innovative/critical thinking, ability to solve problems and meet deadlines
• Strong communication, organization, presentation, and writing skills

Education and Experience

• Bachelor’s degree (chemistry, engineering, nursing) strongly preferred
• 1 to 2 years’ experience in Quality, Regulatory or Complaint management is preferred
• May consider equivalent combination of education and experience