Mgr Prod Surveillance

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At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

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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 teams activities and KPIs. 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 processes
• Managing 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 regulations
• Managing daily work assignments for the team for activities related to complaint processing to ensure on time complaint processing regulatory reportability determination and reporting
• Managing key performance indicators for the team including creating and/or analyzing operations metrics and reports to identify improvement opportunities
• Overseeing and providing regular updates and reports on team performance and key metrics to management
• Participating in resolution of escalated issues. Identifying and escalating issues as appropriate; ensuring Postmarket Surveillance leadership is informed of high risk issues in a timely manner
• Leading and/or participating in cross functional activities and projects including NCRs/CAPAs
• Participating and/or leading audit readiness activities and efforts for Postmarket Surveillance function including potential risk identification mitigations and improvements
• Participating 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 needed
• Maintaining a high level of expertise in current regulatory requirements
• Reviewing and revising written Procedures and submitting procedural changes as needed
• May 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 organization
• Ability to effectively manage and lead people and encourage teamwork
• Ability to motivate develop and influence others
• Strong 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 skills
• Ability to drive decisions and actions quickly and effectively
• Ability to make independent decisions
• Understanding of scientific strategies and ability to invent new methods or new avenues of analyzing large data
• Ability to deal with ambiguity
• Collaboration and Teamwork
• Detail Oriented
• Customer Focus
• Strong technical writing skills

Education and/or Experience:

• Bachelors 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

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