Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Our 109,000 colleagues serve people in more than 160 countries.
About Abbott
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive.
Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.
Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.
A healthy heart is essential to good health.
That’s why we’re committed to advancing treatments for people with cardiovascular disease.
As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster.
We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in Sylmar, CA, currently has an opportunity for a CAPA & Learning Supervisor.
WHAT YOU’LL DO
Working under general supervision, exercises direct supervision over the group responsible for Learning Management System (LMS) training and implementation, while adhering to department and company Detailed Work Instructions (DWIs) and Standard Operating Procedures (SOPs).
Applies business knowledge and/or principles/methods normally acquired in a recognized four-year course of study or equivalent work experience.
Trains and mentors subordinates and site personnel in the use and application of the company’s LMS software, using practices that enable them to effectively perform their jobs within the multi-site organization.
Promotes the process of continuous quality improvement and coordinates solutions for administrative and personnel issues.
Troubleshoots complex problems.
Exercises judgment in planning and organizing work; monitors performance and reports status.
Responsible for the employment, training, motivation, counseling and discipline of employees supervised.
Assists employees in understanding and compliance with St.
Jude Medical policies and practices.
In addition, this position is responsible for facilitating and executing the CAPA process.
Job Duties:
Ensures staff is appropriately trained in processes and procedures related to LMS; ensures established processes and procedures are being followed and documented.
Accountable for the performance of subordinates and work output of managed subcontractors.
Maintains a safe work environment and a strong customer focus.
Create Detailed Work Instructions (DWIs) pertaining to LMS, CAPA and training processes.
Partner with company managers, internal and external developers, course owners and other stakeholders to ensure effective administration of the LMS.
Maintain open communication and build strong relationships to successfully execute role.
Launch new courses within the LMS, build associated learning activities, audiences, and properties; execute proper testing protocols consistently to ensure flawless implementation.
Review/audit and rebuild existing course structures, audiences, and curricula for improved functionality.
Schedule ongoing reviews to ensure all course content is active and in good working order.
Develop new and revise existing courses on request, working in conjunction with managers to ensure quality and timeliness of content.
Provide technical information concerning related systems, applications, institutional standards, requirements, objectives, and policies and procedures.
Troubleshoot all system issues through to satisfactory resolution.
Maintain updated documentation such as issue tracking log, master course catalog, training request forms, development guidelines and user manuals relevant to LMS.
Develop and implement training programs for LMS users ensuring complete knowledge of system.
Responsible for overall quality control of both system and content.
Develop, produce, and distribute reports based on LMS data for management and/or audit use.
Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.
Lead meetings and communications for CAPA updates, information, and concerns.
Responsible for assisting with CAPA and training metrics and reporting on regular basis in accordance with established procedures.
Support team in the delivery and oversight of CAPA training program.
Define and allocate resources needed to meet established project schedules.
Establish functional goals, strategies, and tactics to assure optimal customer service.
Aid in the preparation of budgets as related to training, personnel, and training records.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
Maintains a safe and professional work environment.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S.
Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelors or Associate’s Degree in Engineering or Science with relevant medical device experience of minimum of 4 years Experience with LMS or other training software management or use.
Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
Solid communication and interpersonal skills.
Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
Advanced computer skills, including statistical/data analysis and report writing skills.
Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner.
Experience working in a broader enterprise/cross division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career.
We offer:
Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.