Compliance Specialist II
About Employer
It is a leading global provider of automated laboratory instruments and solutions. Our systems and components help people working in clinical diagnostics, basic and translational research and drug discovery bring their science to life
Responsibilities
Responsible for the daily operation of the quality assurance processes included but not limited to CAPA, , Auditing, Nonconformance Reports, Calibration, Customer Facing activities such as Complaint Management, Quality Holds, Field actions, Customer Quality surveys). Multi-task on a variety of Quality System improvement initiatives in a hands-on environment to ensure company products are in compliance with required regulatory agency requirements. (i.e., FDA, ISO 13485, etc.)
Territory includes: Morrisville, NC
Requirements (skills/educational, professional, personal) Skills - Possess understanding of FDA Quality System Regulations and ISO 13485 - Ability to work well under pressure, to multi-task - High level of commitment and initiative - Ability to influence others and lead/coach other employees to complete required documentation for CAPA/NCR, etc. - Must be responsive to internal stakeholders and customers - Must be computer literate and familiar with Microsoft office products. Microsoft Visio skills desired. - Occasional travel is required. - Requires excellent written and verbal communication skills, including good facilitation skills, excellent presentation skills and engaging presentation style. Must have good technical writing skills - Quality auditing and CAPA experience desired. - Strong attention to detail required - Ability to prioritize. Ability to manage time effectively. - A desire to make the difference!
Education
Bachelors degree
