Position SummaryProvide quality leadership and technical guidance on preventative quality within operations and other business functions at local and global level, advocating and leading the execution of initiatives & projects to enhance quality performance within the business.
Mentor and provide technical direction across multiple areas of expertise.
Ensure compliance to regulation and standards.
Position RequirementsWill work within the quality team on projects, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Work on Quality projects related to cost out and continuous improvement.Work closely with business functions to assess, provide oversight and direction on quality performance of product and processes.Coach and mentor the quality team and other business functions in quality topics and activities, with several topics at expert level.Lead/manage quality initiatives/projects at local & global level.Recognized process owner in areas of expertise, with expertise across multiple areas including problem solving, risk, concession & change management, lean, six sigma, CAPA, statistics, validation, inspection processes & sampling, etc.Provide input into local, global & corporate processes, serving as a representative on review & discussion boards and teams for expert & valued input.Provide input/assessment and justification at expert level during concession/change management and quality issues.
Review and approval of the same, driving strong review.Interpret KPI trends and take action as necessary, driving a continuous improvement process.Advocate for Human Factor practices, proficient in the science of Human Factor identification and mitigation.Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business.
Oversight/deputize for audit management, logistics, and preparation as required.Aid in the development of validation strategies, certified in multiple disciplines of validation to approval level.Support/lead manufacturing transfers to other plants/facilities, leading quality activities.Deputize proficiently for management in temporary absence, periodic review boards, business meetings, etc.
on a regular basis.
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