Medical Device Compliance Trainer/Lead (Competency)

Fort Myers, FL

Job ID: 124352 Industry: Med


Medical Device Compliance Trainer/Lead (Competency)

Global medical device company and leader in new product development and medical education in orthopedics. They are looking for a Compliance Specialist focusing on personnel competency.

Principle Duties and Responsibilities:
Our client is looking for a compliance specialist that will correspond according to ISO 13485 and ISO 9001 requirements. According to the FDA, our manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. The objective of this work is to fully implement competency training and assessments for targeted departments/job titles/tasks across the company. They will provide training on new and revised competency-related work instructions and forms. Hand-hold department through discovery process and new template/ work instruction application. Help map job tasks to associated procedures and work instructions. Assist in conducting Task Analysis to determine task severity. Provide instructional design support to help identify level of training and assessment needed, and help develop the content and assessments. Help document the above in department level work instructions where necessary. Work with the larger project team to ensure assigned departments meet the timeline and expectations established. Prepare for internal and external audits of ISO 13485: 2016 Standard, 6.2 clause. All of these activities require objective evidence, in the form of records, to demonstrate the QMS operation. They are essentially going to be making sure every personal is qualified to do their job according to FDA regulations within the medical device industry.

Medical Device
Job Competency Testing/Procedures
ISO 13485

Job Type: Contract 

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