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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
Support NCR/CAPA activities as needed, including but not limited to: Quality Approver role
Capa Review Board chair
Seen as the expert by peers and other personnel on NCR/CAPA process – provide training and coaching to NCR owners and approvers
Utilize DMAIC tools to promote a disciplined non-conformance investigation approach and participates in corrective and preventive actions (CAPA)-related activities
Support the R&D sites in other Quality areas as needed, including but not limited to: Analysing data from various sources (Non-Conformances, Field Corrective Actions, Medical Device Reports, Audit Observations, and Complaints) to drive decisions
With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project
Supporting Quality internal and external audits. Serves as an internal auditor if required
Educates and trains peers or subordinates on global and/or local Medical Device processes
Organising and presenting technical information, as necessary, and be recognized as a technical subject matter expert
Requirements:
Understanding of Quality Management System Concepts, including NCR/CAPA Management
Assertive and accountable for anticipating and resolving problems
Excellent interpersonal and collaboration skills, and willingness to work independently
Work with cross-functional teams across the globe to support, guide and deliver results
Engineering/Science degree with 5-7 years related engineering/science/quality experience
Previous NCR/CA experience and expertise on the NCR/CAPA process is considered a valuable asset for this role