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As Assoc II, Quality, you will lead multi-functional teams as an Owner of Field Interventions. You will facilitate the execution and closure of multiple US/global Field Actions. This position supports additional field action process activities as detailed below.
Job Responsibility:
Responsible for handling Field Actions (FAs) as FA Owner through FA closure
Lead daily departmental activities for areas of direct responsibility
Lead activities of self and Field Action (FA) team members in achieving defined Quality/FA goals
Participate in FA review boards and Monthly reviews when vital, coordinate approvals for FA related documents, and drive FAs to closure per approved plans
Lead FA Strategy team meetings to draft customer letters and Global FA Plans with global multi-functional teams
Collaborate with internal customers on issues and questions related to the implementation of FAs
Prepare and Verify FA monthly status reports
Assist with data collection and report generation
Perform periodic reviews for FA communications and coordinate efforts with other FA staff to ensure accurate documentation and data is assembled, entered and stored appropriately
Work closely with regional gatekeepers, business leads, and FA team members to implement and support FA plans, supervise FA completion and resolve issues to drive FA’s to closure
Present FA Metrics to management on an as needed basis and participate in internal and external inspections and assist with implementing solutions to audit findings
Be directly involved in, and where appropriate, lead improvement projects which may include improving current FA processes, data generation, report development and presentation, or improving other quality processes /systems to demonstrate lean proficiencies
Prepares periodic metrics for executive and segment management reviews, as needed
Requirements:
Bachelor’s degree in sciences or engineering
3-5 years of experience in Quality with a Medical Device/Pharma company or other similarly supervised industry