Responsible for quality assurance operation in the Devices/Molding Focus Factory. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Provide incoming, in-process and finished goods testing support. Involved in the development and revision of new standard procedures and training of employees. Assist department managers in audits or assessments and closures. Analyze and complete customer complaints. Perform department equipment and process validations. Serve as technical liaison among QM functional groups as well as other departments in the plant. Review and release in-process and finished materials. Provide final approval, sign-off and release of in-process and finished materials. Write, review and revise SOPs. Perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Develop plans to correct identified risks and implement these plans. Maintain current and powerful expertise in quality systems and quality techniques. Maintain a high level of expertise in current regulatory requirements and technical issues. Assist in training staff and maintain training files. Perform equipment/process validation and/or equipment/process revalidation reviews. Implement company policies and assure conformance to specifications and plant procedures. Develop improved product sampling and measurement technology. Conduct defect/failure analysis on product as required. Perform process capability, and statistical process control studies on multiple product lines. Support Manufacturing and Quality Management with the development and implementation of new processes/technology. Assist in the identification and development of process improvement projects. Must have knowledge of both plant and department environmental health and safety regulations and follow said regulations accordingly. Must perform all other duties and responsibilities as determined by supervision/management. May include supervision of direct reports from multiple shifts. Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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