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| 581317Global QARA Training Mgr WI 100k (J#13319) Education: Bachelors Degree Experience: 4 - 9 years Essential Functions (Responsibilities): The Global QARA Training Manager is responsible for the development, execution & validation of the QA and RA training & development strategy/framework & resulting programs & processes across GE Healthcare (GEHC). In addition, the incumbent is responsible for assuring training programs support a regulatory compliance culture at GEHC through skill based learning & required employee knowledge. He/She will be responsible for ensuring all training is compliant with GEHC's Quality Management System & all applicable medical product regulations (FDA, EU, etc). This position will require maintaining an up-to-date knowledge of medical product regulations to ensure that GEHC's training programs are current & employees are trained & aware of the latest regulatory requirements. Key responsibilities include: -Formulate the strategy, priorities, plans, recommendations & deployment of standard & consistent QA training. -Manage the central QA/RA training team (7 direct reports) to meet the goals & objectives for the QA/RA training function globally -Establish global procedures for a) identifying individual training needs, b) ensuring appropriate personnel are trained, c) ensuring individual training needs & plans are documented & readily available -Conduct skill gap assessments & address through necessary education and training -Understand critical skills & abilities required to perform a role within the context of quality & compliance -Ensure all levels of employees have knowledge, skills, & abilities to consistently perform their job at a high level of compliance -Develop training content & delivery mechanisms & methods for different types & segments of training -Lead the central QA/RA training team to develop & deploy all QA/RA training to ensure it is consistent with the global vision for QA/RA training across GEHC -Develop training content & delivery mechanisms & methods for different types & segments of training globally uncluding GE instructor led courses Qualifications/Requirements: -Bachelor's degree or high school diploma and 7 years of experience developing training programs and deploying them across a global organization. -Familiarity with Quality processes and tools. -Familiarity with a manufacturing environment, including all aspects of product development. -Demonstrated experience working in a regulated environment, requiring adherence to government or regulatory body policies and procedures. -Demonstrated experience leading teams virtually. -Demonstrated project management experience developing processes and leading their implementation in a cross functional environment. -Demonstrated ability to lead and influence behavioral change in a matrixes environment -Demonstrated ability to effectively communicate (oral and written using English) across a cross-functional organization, up to business leadership and down to individual contributors. -Demonstrated experience successfully working with teams across many, cultures and/or work sites. -Ability to travel domestically and internationally as needed. -Prior experience and proficiency with word processing, spreadsheet, and presentation software -Must submit your resume through gecareers.com or a job board to be considered for this specific job opening (internal candidates should apply through COS). -Must be willing to take a drug test as part of the selection process -Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background -Must be legally authorized to work in the United States without work sponsorship at time of hire. -Must be willing to work in Waukesha, Wisconsin. Desired: -Master's degree and 10 years experience developing, implementing and leading training activities -Prior Experience with medical devices or the pharmaceutical industry -Familiarity with FDA, QSR, ISO 13485, training in a regulated industry, and other quality system regulations -Demonstrated ability to interface with top organizational leadership, internal/external customers and external regulatory agencies in a professional manner -Able to respond/react with appropriate urgency/professionalism & make decisions under pressure/stress -Influencing/advocacy-able to determine a position & argue it effectively within the business context -Familiar with continuous improvements in a manufacturing environment -Effective interpersonal and networking skills -Strong business acumen-uses financial analysis to make important business decisions & understands key financial metrics, can articulate the company's business vision & key business objectives, understands business trends & cycles | |||
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