Complaint and Training Coordinator

Job Description:

The Complaint and Training Coordinator plays an integral role in ensuring that the company is compliant with complaint handling documentation and reporting activities as well as training documentation activities relative to the company’s GMP system. Additionally, this position provides document control support during times of heavy documentation overflow or if the documentation control manager is unavailable.  

Duties and Responsibilities:

This position is responsible for ensuring compliance with AVI’s complaint handling SOP. Primary duties include:

• Reviewing sources of potential complaints and ensuring complaints are identified, disseminated internally for review, investigated and reported in a timely fashion consistent with internal procedures and metrics
• Interacting with members of AVI’s sales, clinical, marketing and engineering teams as well as customers gather information and appropriately report complaint findings
• Conducting complaint meetings in which trending reports and status update reports are provided to team members or management as directed by the Head of QA 
• Preparing and maintaining complaint files
• Reporting reportable events to government officials as required

This position is responsible for ensuring compliance with AVI’s internal training SOP. Primary duties include:

• Working with DCO authors to ensure the appropriate individuals are correctly identified for training/re-training
• Maintaining training records and electronic files supporting compliance
• Working with individual employees to ensure they are aware of their training needs and complete documentation of their compliance in a timely fashion per the SOP
• Tracking and reporting compliance metrics per company quality objectives

This position provides back up support in other Quality areas including Document Control.

Qualifications:

• Minimum of a Bachelor’s degree required
• A minimum of 3 years of working as a complaint handler in the medical device industry
• Experience using pivot tables and generating complaint metrics
• Understands good documentation practices and has worked with controlled documents
• Experience with MS excel

Exposure to electronic complaint handling systems is desirable

Physical Demands: 

The physical activities described within the job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

Access Vascular, Inc is a proud Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.