Assoc. Mgr, Prod Surveillance

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Summary:

This role is responsible to supervising the team responsible for handling of complaints 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 tasks completion decision-making empowerment of others problem solving and team leadership. A functional 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
• Supervising employees to ensure achievement of operational goals and KPIs and ensuring team adherence to established processes and regulations
• Managing daily work assignments for the team and distributing daily assignments to the team to ensure on time complaint processing regulatory reportability determination and reporting
• 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
• Identifying and escalating issues as appropriate; ensuring Postmarket Surveillance leadership is informed of high risk issues in a timely manner. Participating in resolution of escalated issues and risks as assigned
• Leading and/or participating in cross functional continuous improvement activities and projects including NCRs/CAPAs
• Participating in audit readiness activities and efforts for Postmarket Surveillance function
• 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 as needed
• Maintaining a high level of expertise in current regulatory requirements
• Performing Post Market Surveillance tasks as assigned by line manager

Qualifications:

• Ability to effectively communicate (verbal and written) across different functions and across multiple levels within the organization
• Ability to effectively lead a team motivate and influence
• Strong understanding of complaint process and regulatory reporting 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
• 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)
• 5-8 years of experience in Quality or related field in the medical products industry
• Experience with leading people (directly or indirectly through project teams)

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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