Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

https://www.youtube.com/watch?v=X0h_0ih8MgQ

Essential Duties and Responsibilities:

•   Set Quality system requirements to suppliers within the employee’s defined commodity portfolio,
•   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
•   Oversee and negotiate Quality Agreements between suppliers and Baxter.
•   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, ISO 9001, FDA cGMP, MDD, Eudralex, other global or regional equivalent
• Working knowledge of US and International cGMP as it applies to the defined commodity portfolio
• 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 35%)

Education and/or Experience:

Include the education and experience that is necessary to perform the job satisfactorily.

• Higher level of technical education (e.g., Science degree, Diploma, or Alternative technical Bachelor’s degree or non-technical degree, diploma or Certificate);
• Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus  (e.g., automotive, aerospace, combination products, pharmaceuticals)
• Manufacturing experience is preferred in resins, plastics, and molding; or API, excipients and chemicals; or packaging, glass, needles, and medical devices. Experience with other commodities relevant to medical devices or pharmaceuticals will also be considered.
• Experience performing laboratory methods
• Experience auditing manufacturing facilities relevant to the defined supplier commodity portfolio
• 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

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.