Sq Lead

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**This is Where** you save and sustain lives.

**Summary/Essential Duties and Responsibilities**:

- Manage SQ activities and responsible for results in terms of compliance, metrics and conformance to regulations and Baxter quality policies.
- Management and execution of supplier audits, negotiation and implementation of Quality Agreements, assessments to analyze compliance and risk and set Quality system requirements to suppliers according to the commodity portfolio (being Raw Materials, Finished Products or Services).
- Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and process simplification.
- Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures.
- Assist in preparing for inspections by external agencies or internal Baxter audits.
- Develop and/or deliver training to internal teams and suppliers.
- Management of Supplier Corrective Action Request (SCAR) and Risk Assessment & Mitigation (RAM).
- Support Manufacturing, Regulatory, Quality, R&D and Purchasing organization or all other Location of Use (LOU) organization for third party suppliers related activities, as applicable.
- Willingness to travel (up to 30-35%).

**Qualifications**:

- Prior auditing experience; Lead auditor qualification (up to and including certified SQ lead auditor training); Strong technical writing skills and must be able to clearly document audit findings within audit reports; Quality Management System auditing.
- Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, ISO 9001, ISO 17025, FDA cGMP, MDR, Eudralex, GAMP 5, IEC62304, other global or regional equivalent; Working knowledge of US and International cGMP as it applies to the defined commodity portfolio.
- Experience in production/quality development and control methods; CtQ definition, APQP, PPAP, FMEA, Control Plans among others.
- Competence in supporting on-site/off-site supplier quality development including coordination/management of resources.
- Ability to manage the Quality relationship with assigned key suppliers/stakeholders.
- Strong analytical and problem solving skills and process mindset; Attention to details and passion for Quality.
- Ability to manage/supervise a team of employees (if applicable/necessary).
- Good communication, interpersonal, influencing, negotiation, leadership, collaboration and teamwork skills.
- Project management skills managing multiple issues of moderate to high complexity relatively independently with mínimal supervision/instructions Knowledge of Business Acumen
- Multi-tasking skills in a demanding fast paced environment

**Education/Experience**:

- 5+ years’ experience in Quality, Manufacturing, Engineering or related field.
- Higher level of technical education (e.g., Science degree, Diploma, or Alternative technical Bachelor’s degree or non-technical degree, diploma or Certificate)
- Experience auditing manufacturing facilities or 3rd party Service Suppliers in pharmaceuticals or medical devices (cross-industry experience is a plus e.g., automotive, aerospace, combination products, medical devices and pharmaceuticals).
- 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 Power Point - MSOffice.

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

108580