Assistant, Supplier Quality（契約社員）

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Summary:

Serve as the technical expert within SQ department(s) in the Quality organization. Responsible for results in terms of quality and conformance to regulations and Baxter quality policies.

Independently manages Supplier Quality Assurance activities, including: 

• Setting quality management system requirements for suppliers.
• Managing and overseeing approved supplier list and related supplier master files.
• Ensuring adherence to audit schedule and performance of audits only by qualified auditors.
• Tracking and trending supplier quality metrics.
• Coordinating purchasing controls CAPA activities, ensure timely and effective closure.

Essential Duties and Responsibilities:

• Set Quality system requirements to contract manufacturers and suppliers, including those for services, indirect quality relevant purchases (non-BOM), and QS requirements for suppliers in global markets.
• Perform Qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL), including ensuring the creation and maintenance of supporting evidence (Supplier Master File).
• Conduct and oversee supplier audits-qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics.
• Improve/develop quality systems at selected suppliers for QMS and compliance improvement.
• Develop purchasing controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods.
• Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements.
• Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure.
• Develop and/or deliver training to internal teams and suppliers.
• Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed.
• Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions.
• Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

Qualifications:

• Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, cGMP, MDD, EudraLex, other global or regional equivalent
• Knowledge in new part/product qualification for medical devices, pharmaceutical products, API and Excipients.
• Experience in Product/process development and/or supplier quality improvement.
• 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, including certified SQ lead auditor training, Quality Management System auditing, and where possible, special process auditing skills.
• Knowledge in current and possible future policies, practices, trends, technology, and information affecting his/her industry and organization.
• 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.
• Competence in supporting on-site/off-site supplier quality development including coordination/management of resources.
• Multi-tasking skills in a demanding fast paced environment
• Superior time-management skills
• Attention to details and a passion for quality.
• Superior written and oral communications skill sets – Fluent in English
• Willingness to travel (up to 40%)

Education and/or Experience:

• Bachelor's degree in a scientific discipline with 5-7 years of experience required or Master's degree in a scientific discipline 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)
• For SQ Assurance Associates supporting drugs, Pharmaceutical Manufacturing experience is preferred.
• 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

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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