Quality System Training Manager

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

We are seeking a customer service focused and business process-oriented Quality Systems Training Manager to join the Electrophysiology Business Unit within Abbott’s Medical Device Division.  This role reports to the EP Quality Engineering Services Director.

Quality System Training Manager

Working under general supervision, manage and lead the team responsible for Quality System Training and the Learning Management System (LMS) software.  This team is responsible to ensure all Business Unit employees are receiving and completing required Quality System training in a timely manner.  Create a team culture in which customer service is the primary focus.  Develop and implement improved processes and tools to drive efficiency and accuracy.

Responsibilities:

• Lead a team to critically analyze, develop and implement improved process and tools while adhering to department and company Detailed Work Instructions (DWIs) and Standard Operating Procedures (SOPs).  
• Interface and collaborate with IT to troubleshoot, build, test, and implement additional technology improvements.
• Resolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence.
• Provide input and/or write department SOPs, policies and project plans for future training development.
• Ensure processes and documentation are in place to satisfy on-site inspection and audit activities.  Support internal, external and regulatory agency audits.
• Work with management and other departments to streamline processes, create efficiencies, and implement improvement projects.
• Interface with the document management system (PTC Windchill PLM) including collaboration with the Document Services team.
• Collaborate with leaders across other Business Units which share the same tool platform to drive consistency and improvement.
• 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.
• Develop, produce, and distribute reports and metrics based on LMS data to monitor the health of the Quality System, for management needs, and audit use.
• Create a team culture in which internal customer service is the primary focus.
• Ensures staff is appropriately trained in processes and procedures related to LMS.
• Ensures established Quality System training processes and procedures are being followed and documented for business unit employees.
• Accountable for the performance of subordinates and work output of managed subcontractors.
• Responsible for the employment, training, motivation, guidance and discipline of employees supervised. Assists employees in understanding and compliance with Company policies and practices.
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback. Set goals which align to department plans and manage the execution of goals through coaching and mentoring.
• Establish functional goals and strategies to assure optimal customer service.
• Oversight of the launch of new courses within the LMS, building of associated learning activities, audiences, and properties. Oversight of the review/audit and rebuilding of existing course structures, audiences, and curricula for improved functionality.
• Evaluate quality process and system standards to ensure compliance with standards and regulatory requirements.
• Aid in the preparation of budgets related to training and personnel.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply 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.
• Maintain a safe work environment.

Qualifications:

Education Level Major/Field of Study or Education Level

Associates Degree Business Administration or a related field, or an equivalent combination of education and work experience.

Experience Details:

• Minimum 8 years: Demonstrated progressively more responsibility and experience leading a highly engaged team
• Experience with a learning management system or other technical software. 
• Proven customer service focused background and recognized as having a collaborative style
• Ability to think critically to redefine and rebuild the processes and tools utilized to support a large, dynamic organization
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Must be able to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and company operating procedures, processes, policies, and rules.
• Demonstrated personal computer skills including a working familiarity with various software which may include relevant training systems, databases, spreadsheets, or specialized applications.
• Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization are essential.
• Ability to multi-task, prioritize and meet deadlines in timely manner.

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