Baxter International Inc.
Supplier Quality Assurance Lead (Injection Molding Expert)
Baxter International Inc., Deerfield, Illinois, United States, 60063
Overview
Supplier Quality Assurance Lead (Injection Molding Expert) at Baxter. Saving and Sustaining Lives at Baxter begins with the suppliers who make the raw materials that form our products. The role provides a high-visibility opportunity to ensure Baxter’s suppliers continue to enable our Mission by providing high quality, safe, and effective products. You will work with Americas Raw Materials suppliers throughout their lifecycle from onboarding, maintenance, supplier performance review, supplier audits and supplier quality development. What you will be doing
Supplier Development: Improve/develop quality systems at selected suppliers for QMS and product quality improvement; execute SCAR management with effective and timely closure; collect, trend and report supplier performance metrics; manage and oversee Supplier CAPA including root cause identification and timely closure; develop and/or deliver training and process improvement to internal teams and suppliers. Supplier Qualification / Maintenance: Perform qualification of component and medical device, and combination device suppliers; conduct and oversee supplier audits-qualification and re-qualification, including finding closure; evaluate and improve the effectiveness of purchasing controls and supplier quality processes; assist in preparing for and defending Purchasing Controls in inspections; coordinate duties related to acquisitions or divestitures with the facility and ensure live or divested status in the GSQ TrackWise database; support Manufacturing, Regulatory, Quality and Purchasing for third party supplier activities as applicable. What do you bring
Bachelor's degree in life sciences or engineering Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience is a plus (e.g., automotive, aerospace, combination products, pharmaceuticals) Manufacturing/Quality experience preferred; experience with other commodities relevant to medical devices or pharmaceuticals may be considered Experience in root cause analysis and CAPA methods; proficiency with quality tools (6-Sigma / 8-D / CAPA / FMEA / 5WHY) Experience with data analysis and reporting using Excel and statistical/process packages (e.g., Minitab); proficiency with PowerPoint Knowledge of medical device regulations (ISO 13485, FDA cGMP, other global/regional equivalents) and cGMP Experience in Product/process development and/or supplier quality improvement Injection molding and device manufacturing knowledge; SQA with technical background and quality development/control methods Auditing skills including SQ Lead Auditor training; quality management system auditing; process auditing skills Project management skills for multiple issues of moderate to high complexity Ability to manage quality relationships with assigned suppliers/stakeholders Willingness to travel within North and South America (up to 40%) Compensation and benefits
The estimated base salary for this position is $112,000 - $154,000 annually. The range reflects anticipated compensation and may vary by location, skills, experience, and other factors. This position may be eligible for discretionary bonuses and long-term incentives. For questions about pay and benefits, speak to the recruiter during the interview process. Baxter is committed to equitable pay and transparent practices. Benefits
US Benefits at Baxter include comprehensive medical and dental coverage from day one, life and disability insurance, and travel accident coverage. Retirement benefits include a 401(k) plan with company matching and the Employee Stock Purchase Plan. Additional benefits include Flexible Spending Accounts, educational assistance, paid holidays, paid time off, parental leave, commuting benefits, Employee Discount Program, Employee Assistance Program, and childcare benefits. For more information, contact your recruiter or visit the Baxter Benefits site. Equal Employment Opportunity
Baxter is an equal opportunity employer. Qualified applicants are evaluated without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability, or any other legally protected characteristic. Reasonable Accommodations
Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation for the application or interview process, please contact us with your request. Recruitment Fraud Notice
Baxter has identified instances of employment scams. To protect yourself, review Baxter’s Recruitment Fraud Notice.
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Supplier Quality Assurance Lead (Injection Molding Expert) at Baxter. Saving and Sustaining Lives at Baxter begins with the suppliers who make the raw materials that form our products. The role provides a high-visibility opportunity to ensure Baxter’s suppliers continue to enable our Mission by providing high quality, safe, and effective products. You will work with Americas Raw Materials suppliers throughout their lifecycle from onboarding, maintenance, supplier performance review, supplier audits and supplier quality development. What you will be doing
Supplier Development: Improve/develop quality systems at selected suppliers for QMS and product quality improvement; execute SCAR management with effective and timely closure; collect, trend and report supplier performance metrics; manage and oversee Supplier CAPA including root cause identification and timely closure; develop and/or deliver training and process improvement to internal teams and suppliers. Supplier Qualification / Maintenance: Perform qualification of component and medical device, and combination device suppliers; conduct and oversee supplier audits-qualification and re-qualification, including finding closure; evaluate and improve the effectiveness of purchasing controls and supplier quality processes; assist in preparing for and defending Purchasing Controls in inspections; coordinate duties related to acquisitions or divestitures with the facility and ensure live or divested status in the GSQ TrackWise database; support Manufacturing, Regulatory, Quality and Purchasing for third party supplier activities as applicable. What do you bring
Bachelor's degree in life sciences or engineering Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience is a plus (e.g., automotive, aerospace, combination products, pharmaceuticals) Manufacturing/Quality experience preferred; experience with other commodities relevant to medical devices or pharmaceuticals may be considered Experience in root cause analysis and CAPA methods; proficiency with quality tools (6-Sigma / 8-D / CAPA / FMEA / 5WHY) Experience with data analysis and reporting using Excel and statistical/process packages (e.g., Minitab); proficiency with PowerPoint Knowledge of medical device regulations (ISO 13485, FDA cGMP, other global/regional equivalents) and cGMP Experience in Product/process development and/or supplier quality improvement Injection molding and device manufacturing knowledge; SQA with technical background and quality development/control methods Auditing skills including SQ Lead Auditor training; quality management system auditing; process auditing skills Project management skills for multiple issues of moderate to high complexity Ability to manage quality relationships with assigned suppliers/stakeholders Willingness to travel within North and South America (up to 40%) Compensation and benefits
The estimated base salary for this position is $112,000 - $154,000 annually. The range reflects anticipated compensation and may vary by location, skills, experience, and other factors. This position may be eligible for discretionary bonuses and long-term incentives. For questions about pay and benefits, speak to the recruiter during the interview process. Baxter is committed to equitable pay and transparent practices. Benefits
US Benefits at Baxter include comprehensive medical and dental coverage from day one, life and disability insurance, and travel accident coverage. Retirement benefits include a 401(k) plan with company matching and the Employee Stock Purchase Plan. Additional benefits include Flexible Spending Accounts, educational assistance, paid holidays, paid time off, parental leave, commuting benefits, Employee Discount Program, Employee Assistance Program, and childcare benefits. For more information, contact your recruiter or visit the Baxter Benefits site. Equal Employment Opportunity
Baxter is an equal opportunity employer. Qualified applicants are evaluated without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability, or any other legally protected characteristic. Reasonable Accommodations
Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation for the application or interview process, please contact us with your request. Recruitment Fraud Notice
Baxter has identified instances of employment scams. To protect yourself, review Baxter’s Recruitment Fraud Notice.
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