What are the responsibilities and job description for the Specialist, Quality Systems (Training & Documentation) position at Abbott?
The Opportunity
This position can work out of our Livermore, CA or Orlando, FL location in the Abbott Heart Failure, Acelis Connected Health business. Our Heart Failure solutions are helping address some of the World’s greatest healthcare challenges.
As the Senior Document Control and Training Specialist, you are responsible for ensuring processes associated with Quality Training System are in compliance to internal and external regulations, procedures and standards.
What You’ll Work On
Manage the site Documentation System and the QA Work Order systems.
Assure that all QA documents meet established divisional, corporate and regulatory standards and that these documents are an efficient, effective system for both their use and Quality Assurance.
Identify gaps in Documentation and Systems and take necessary actions to correct.
Ensure change requests identify all documents affected and all appropriate parties are reviewing the document prior to implementation to assure change control is achieved.
Updates global and local standard operating procedures and work instructions.
Interface with SMEs; business functional areas and site QA as necessary to design and develop QA training courses / materials to meet business needs.
Responsible for maintaining and reporting on the compliance of the quality training processes.
Analysis and generates data and KPI metrics related to Quality Training for inclusion in Management Reviews.
Maintain the data integrity of SUMTotal LMS to ensure training data is audit ready at all times.
Work closely with Division QA and site QA leadership to continuously improve QA training.
Provide guidance and direction to QA training resources at the site. Balances the team’s workload and is responsible for performance management.
Help to conduct QA training needs assessments and gap analysis.
Help establish training effectiveness measures and evaluate QA training effectiveness. Analyze data to drive continuous improvement of QA training content.
Responsible for the ongoing evaluation and implementation of continuous improvement in relation to QA training / learning materials / courses.
Required Qualifications
Bachelor’s Degree (± 13 years) or relevant education and experience
Preferred Qualifications
2 or more years of medical device related experience
Strong Experience with Doc Control and Training Systems
Knowledge of Regulated Industries
