Senior Specialist, Quality Training

3 weeks 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:** • 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) • Interpret internal requirements and external regulations and standards as they relate to training and implementing measures to meet those requirements. • Identify and assess training related root cause and lead the implementation of corrective actions in initial non-conformance investigations • Provide complex analysis on training course materials to evaluate, provide recommendations and lead the implementation on appropriate training effectiveness measures • Develop and present training materials for quality system related processes • 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 • Contribute process knowledge to, and develop proposed modifications while identifying new alternatives to resolve complex issues on Quality, Engineering, and Manufacturing projects, as part of cross-functional technical groups. • Summarize data to develop routine criteria for evaluating effectiveness of training activities • Provide coaching and knowledge transfer to other team members • Perform adhoc LMS functions to address the business needs • Incidental: Other duties as assigned by management **What you'll need (Required):** • Bachelor's Degree in in related field • 5 years’ experience of previous related experience **What else we look for (Preferred):** • Experience working in a medical device, healthcare, or a similarly regulated environment • Experience with 'Learning Path' Learning Management Systems (LMS) • 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 • Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance • Full knowledge of Good Documentation Practices (GDP) • Full knowledge of the capabilities within Learning Management System (LMS) • Full understanding of quality system regulations • Good leadership skills and ability to influence change • Strict attention to detail • Ability to interact professionally with all organizational levels • Ability to manage competing priorities in a fast paced environment • Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control 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 $78,000 to $110,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements. Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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