Sr Spec, Supplier Quality

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Role Overview

Serves as the technical expert of supplier quality & ECM assurance in the organization. Is responsible for results in terms of quality and conformance to regulations and Baxter quality policies.

Independently manages Supplier Quality Assurance activities and Purchasing Controls activities as Quality department.

Key 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.

• Execute 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/execute/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.

Qualifications / Education / Experiences

• Knowledge of pharmaceutical and/or medical device regulations, e.g. ISO 13485, ISO 14971, FDA cGMP, MDD, EuMDR, Eudralex, ICH Q series, PIC/S and 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.

• Multi-tasking skills in a demanding fast paced environment.

• Superior time-management skills.

• Attention to details and a passion for quality.

• Good written and oral communications skill sets in English.

• Willingness to travel (up to 30%)

• Bachelor's degree in a scientific discipline.

• Requires 5+ years of experience in Quality in healthcare industry.

• 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.

• Experience with data analysis and reporting using basic Microsoft Excel toolkit.

• Experience with creation and revision of documented procedure using Microsoft Word including creation of the difference document.

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

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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