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Summary:

This role is responsible for managing the Product Surveillance team responsible for end to end complaint processing across various products, following the applicable regulations and procedures.  This role oversees and is responsible for the team’s activities and KPI’s.  This role demonstrates effectiveness in managing and leading people, decision-making, empowerment of others, problem solving, and task completions for self and others. A strong understanding of FDA, ISO and Baxter Quality systems is also required. 

Essential Duties and Responsibilities:

Serves as a Subject Matter Expert for PostMarket surveillance processesManaging team, including mentoring, coaching, development, performance management and staffing decisions; and supervising employees to ensure achievement of operational goals and KPIs, and to ensure team adherence to established processes and regulationsManaging daily work assignments for the team for activities related to complaint processing, to ensure on time complaint processing, regulatory reportability determination, and reportingManaging key performance indicators for the team, including creating and/or analyzing operations metrics and reports to identify improvement opportunitiesOverseeing and providing regular updates and reports on team performance and key metrics to managementParticipating in resolution of escalated issues. Identifying and escalating issues as appropriate; ensuring Postmarket Surveillance leadership is informed of high risk issues in a timely mannerLeading and/or participating in cross functional activities and projects, including NCRs/CAPAsParticipating and/or leading audit readiness activities and efforts for Postmarket Surveillance function, including potential risk identification, mitigations, and improvementsParticipating in external and internal Audits as a complaint process Subject Matter Expert, including direct interactions with the Auditor(s), providing support to Audit requests, providing support to responses, and driving completion of Audit commitments, as neededMaintaining a high level of expertise in current regulatory requirementsReviewing, and revising written Procedures and submitting procedural changes as neededMay perform other Postmarket Product Surveillance activities as assigned

Qualifications:

Ability to effectively communicate (verbal and written) across different functions and across multiple levels within the organizationAbility to effectively manage and lead people and encourage teamworkAbility to motivate, develop and influence othersStrong understanding of complaint process and regulatory reporting processes, including FDA regulations applicable to Baxter products (medical devices, pharmaceuticals, etc.)Strong critical thinking and problem solving skillsAbility to drive decisions and actions quickly and effectivelyAbility to make independent decisionsUnderstanding of scientific strategies and ability to invent new methods or new avenues of analyzing large dataAbility to deal with ambiguityCollaboration and TeamworkDetail OrientedCustomer FocusStrong technical writing skills

Education and/or Experience:

Bachelor’s degree (science or engineering preferred) with 5+ years experience in Quality, Manufacturing, Engineering, or a related field.Experience should include 1-2 years of supervisory responsibility, or 7 years relevant experience in Product Surveillance.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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