Quality Associate position in a Medical Device manufacturing company. Perform routine document change control functions of reviewing, editing, and implementing change controls for the company. Identify, monitor, coordinate, and document training. Assisting with all Quality Records as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and is not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
• Follows defined procedures and practices to complete daily work
• Raises issues and concerns to ensure quality standards are met
• Coordinate and facilitate the Change Control Board for change requests
• Maintain Quality Folder organization with updated scanned records
• Ensure process for EDMS are followed and maintained
• Maintain document binders to ensure they contain the latest effective revisions
• Archive Quality Records per approved procedures
• Identify, monitor, coordinate, and document training with implementation of changes or new identified needs.
• Assist with metric compilation as directed
• Work with Quality Systems and all levels of facility personnel to achieve company quality standards
• Other duties as assigned
KNOWLEDGE AND SKILLS:
• Excellent leadership attributes with a customer-oriented mindset
• Ability to follow written instructions and procedures
• Clear and precise documentation and writing skills
• Demonstrates consistency with excellent communication, teamwork and collaboration skills
• Self-motivated with minimal day to day guidance required
• Excellent grammar and communication skills
• Knowledge and familiarity with Microsoft Office
• Analytical thinking and problem-solving skills
• Performs job with accuracy and attention to detail; task oriented
• Experience with EQMS software
• Basic knowledge of MS Word.
• Basic knowledge of MS Excel
• Working knowledge of filing systems
• Excellent organizational skills
• Minimum of high school Diploma with two years’ experience in a medical device industry
• Experience with QSR/ ISO 13485 regulations desired