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Manager, Quality Training

4 months ago

Irvine, United States Edwards Lifesciences Full time

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. You will also ensure that Edwards has the key quality information necessary for regulatory compliance.

**How you will make an impact**:
Plan and direct assigned Quality Training system activities with the accountability for successful completion of assigned deliverables.
Oversee the processing of LMS requests while measuring individual performance and driving accountability.
Ensure job-based training requirements are effectively assigned, executed, and managed across the organization.
Identify technical and/or process issues to determine root cause, propose recommendations and develop strategies for improvement to fill skill/competency gaps in meeting the minimum established LMS and associated Training requirements.
Assess, evaluate impact, and lead the execution of re-validation of LMS system specifications and ensure alignment quality requirements.
Provide guidance to stakeholders on the evaluation and analysis of complex technical information and data related to Training program quality indicators, identifying trends and driving factors, and recommending course corrections.
Develop presentations and procedures and present summaries of trends, potential root causes, and recommended course corrections. Develop and lead the evaluation of impact assessments related to Engineering Change Requests (ECRs) submissions. Assess global requirements in the development of training course and/or exam/certification training materials. Evaluate training materials and ensure local/global sustainability (e.g., revision control, accuracy).
Evaluate and communicate the effectiveness of training delivery through development of meaningful metrics; partner with area leadership to improve training effectiveness measures.
Lead the design and development of complex technical and non-technical instructional activities using various media and related training materials and tools to achieve learning objectives while provide guidance and proactively engaging stakeholders.
Identify opportunities and lead the implementation of changes to drive improvements.
Develop global training specific processes, documentation and enforcement of standard procedures and practices, including providing ongoing LMS Front-end user support for the organization.
**Incidental**: Other duties as assigned by management

**What you'll need (required)**:
Bachelor's degree plus 8 years of previous related experience in training and/or quality compliance; or Master’s degree plus 6 years of previous related experience in training and/or quality compliance.

**What else we look for (preferred)**:
Experience working in a medical device, healthcare, or a similarly regulated environment.
Proven successful project management experience.
Experience with 'Learning Path' Learning Management Systems (LMS).
Full knowledge of Good Documentation Practices (GDP).
Full knowledge of the capabilities within Learning Management System (LMS).
Full understanding of quality system regulations.
Excellent computer skills in MS Office Suite.
Good written and verbal communication skills including negotiating and relationship management skills.
Excellent problem-solving and critical thinking skills.
Good leadership skills and ability to influence change.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $100,000 to $142,000 (highly experienced).