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Senior Supplier Quality Assurance

1 month ago

Cleveland, United States Baxter Healthcare Corporation Full time

Location field must contain 'city, state' or a zip code to perform a radius search (e.g.,

Denver, CO

or

46122 ). City and state must be separated by a comma followed by a space (e.g.,

Houston, TX ) Baxter Healthcare Corporation

Senior Supplier Quality Assurance 137045

in

Cleveland ,

Mississippi

This is a Job Description for a Senior Supplier Quality Assurance in Cleveland, Mississippi. Summary: 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. Duties and Responsibilities: Work on supplier qualification, re-qualification, SCAR (Supplier Corrective Action Request) management, SNC (Supplier Notice of Changes) management, RAM (Risk Assessment and Mitigation) management, accountable for Nonconformance Report (NCR) as assigned for effective and timely closure. Prepare the annual supplier re-qualification/audit schedule and perform supplier audits as a qualified lead auditor as per the schedule. Complete the purchasing processes in the systems as Supplier Quality Approver including maintenance of relevant procedures and trouble shooting in the systems. Prepare for and defend Purchasing/Supplier Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes. Support Business Units, Manufacturing, Fulfillment, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable. Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions. Coordinate duties and responsibilities of acquisition or divestiture with the facility, develop/implement/complete associated protocol and ensure that all requirements have been completed and facility is live or divested in the SQLM TrackWise database. Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable. Perform other duties incidental to the above and assigned by supervisor. Knowledge of pharmaceutical and/or medical device regulations, e.g. ISO 13485, ISO 14971, FDA cGMP, MDD, Eudralex, ICH Q series, other global or regional equivalent are preferred. For SQA with technical background, a good knowledge of production/quality development and control methods; CTQ definition, DMAIC, SPC, APQP, FMEA, Control Plans, etc. Auditing skillsets, up to and including certified Supplier Quality lead auditor training; Quality Management System auditing, and where possible, special process auditing skills. Collaboration and Teamwork: Good communications, facilitation, coordination and team skills. Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions. Ability to manage the Quality relationship with assigned key suppliers/stakeholders. Experience in Product/process development and/or supplier quality improvement; Good knowledge of production/quality development and control methods in healthcare industry. Experience auditing pharmaceutical and/or medical device manufacturing facilities. Experience in root cause analysis, corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as 6-sigma / 8-D / CAPA / FMEA / 5WHY etc. Requirements and Qualifications: Bachelor's degree in a scientific field with 5-7 years of experience required or Master's degree in a scientific field with at least 5 years in relevant discipline. Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals). Experience performing laboratory methods. Experience auditing Medical device and drug manufacturing facilities. Experience in root cause analysis, corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as 6-sigma / 8-D / CAPA / FMEA / 5WHY etc. Experience with data analysis and reporting using basic Excel toolkit and advanced statistical /process packages such as Minitab or Visio and PowerPoint. An Equal Opportunity / Affirmative Action Employer.

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