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• Define and monitor Quality system requirements to suppliers within the Finished Good and Contract Manufacturing space
• Perform Qualification of suppliers of 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, including finding closure; Collect, trend and report supplier quality metrics
• Oversee and negotiate Quality Agreements between suppliers and Baxter.
• Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed
• Improve/develop quality systems at selected suppliers for QMS and compliance improvement
• 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

Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

Qualification-

• Knowledge of pharmaceutical and medical device regulations, e.g., ISO 13485, ISO 9001, FDA cGMP, MDD, Eudralex, other global or regional equivalent
• Working knowledge of US and International regulations as applicable to medical devices and drugs
• 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, DfSS, SPC, APQP, PPAP, FMEA, Control Plans, etc.
• Auditing skillsets, up to and including certified SQ lead auditor training; Quality Management System auditing, and where possible, special process auditing skills
• Knowledge of Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business 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

Willingness to travel (up to 50%)

Education/Experience-

• Auditing experience is required
• Manufacturing experience is preferred in finished goods (medical device and drug) and Contract Manufacturing.
• Degree in Science or Engineering required.  Higher level of technical education preferred (e.g., Science degree, Diploma, or Alternative);
• Requires 7+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, 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.

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.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.