Assoc. Mgr, Prod Surveillance

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At Baxter, we believe every person regardless of who they are or where they are from deserves 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.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job you will find purpose and pride.

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 team s activities and KPI s. 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:

• Bachelor s 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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