Are you looking for a place to lead with excellence?
Your role at Baxter
At Baxter, we are building the best Quality Assurance Systems. We work together to improve processes, enhance systems and achieve excellence in quality for our products.
?What you'll do be doing
Provide leadership and work cross functionally with key business team members globally to ensure the Global Quality Management Systems (QMS) compliance and alignment with applicable regulatory standards and business requirements.
Provide strategic leadership for the implementation and ongoing development of an effective Global QMS
Consult and collaborate with Global Business Process owners to interpret, construct and apply robust processes into our global QMS
Proactively review, analyze and implement opportunities for continual improvement of the Global QMS to meet business needs.
Establish and maintain metrics and feedback mechanisms to lead continued efficiency of the systems to business and regulatory needs. Interpret and implement associated action plans and ensure effective communication to partners.
Often must lead a collaborative effort among members of a project team.
Coaches team members on performance and provides inputs for performance evaluations and development.
Being the main contact for external quality and regulatory agencies
Define the strategy for Audit readiness, coordinates and lead CAPA process and assist as needed with corporate with Quality Systems initiatives
Leads computer system approvals and individual rights and access as required.
Be responsible for the Quality Management System, define and train internal auditors, handle the logistics quality system through a third party.
What you'll bring
Degree in Engineer, Administration or related field required and Internal Quality Auditor Certification
5 years of relevant work experience in Quality Systems Management for medical devices, FDA and ISO13485.
Advance level of English
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