This position sits with in the medical device industry and is responsible for maintaining documentation as supporting continuous improvement to address findings from Internal/External Audits and outputs from various Quality Management Systems.
· Monitor and track employee training records and compliance with quality-related requirements.
· Develop and conduct training for Orientation/Quality System Fundamentals
· Track action items resulting from Internal/External Audits, Management Review, Failure Investigations, Failure Analysis and other Quality System Outcomes to ensure timely completion and continuous improvement.
· Assist in the change control process.
· Maintain and update quality-related documentation, including procedures, work instructions, and records as needed.
· Perform Minor Audits to verify adherence to work instructions, the use of properly labeled & calibrated devices, and the use of properly labeled chemicals within their expiration date.
· Perform other work-related duties as requested, directed or assigned by management.
· Minimum 3-5 years' experience in Quality Management System development, implementation, and execution.
· Experience in Medical Device QMS (ISO 13485) beneficial.
· Excellent problem-solving and analytical skills.
· Proficient in quality management software and documentation systems.
· Detail-oriented and highly organized.
· Ability to work effectively in a team and cross-functional environment.