Baxter International Inc.
Supplier Quality Assurance Lead (Injection Molding Expert),
Baxter International Inc., Deerfield, Illinois, United States, 60063
Supplier Quality Assurance Lead (Injection Molding Expert)
Join to apply for the
Supplier Quality Assurance Lead (Injection Molding Expert)
role at
Baxter International Inc.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our mission is to Save and Sustain Lives, and every individual is empowered to take ownership and make a meaningful impact. This is where your work makes a difference.
Role Summary As a Supplier Quality Assurance Lead you will work in a high‑visibility role to ensure that Baxter’s suppliers continue to enable our mission by providing high‑quality, safe, and effective products. You will collaborate with our Americas Raw Materials suppliers throughout their lifecycle from onboarding, maintenance, performance review, audits, and quality development.
Responsibilities
Improve/develop quality systems at selected suppliers for QMS and product quality improvement.
Execute SCAR management, ensuring effective and timely closure and review/risk assessment of supplier quality notifications and their escalation to SCARs and NCR where needed.
Collect, trend, and report supplier performance metrics.
Manage and oversee Supplier CAPA, including root cause identification and effective and timely closure.
Develop and/or deliver training and process improvement to internal teams and suppliers.
Perform qualification of component and medical device combination 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 and procedures.
Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes.
Coordinate acquisition or divestiture duties with the facility, develop/execute/complete associated protocols, and ensure all requirements are met and the facility is live or divested in the GSQ TrackWise database.
Support Manufacturing, Regulatory, Quality and Purchasing organization for third‑party supplier related activities.
Qualifications
Bachelor’s degree in life sciences or engineering.
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/Quality experience is preferred. Experience with other commodities relevant to medical devices or pharmaceuticals may also be considered.
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.
Experience with data analysis and reporting using basic Excel toolkit and advanced statistical / process packages such as Minitab or Visio and PowerPoint.
Knowledge of medical device regulations, e.g., ISO 13485, FDA cGMP, other global or regional equivalent.
Working knowledge of US and International cGMP.
Experience in Product/process development and/or supplier quality improvement.
Injection molding and device manufacturing experience.
SQA with technical background, good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, 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 about current and possible future policies, practices, trends, technology, and information affecting the industry, business and organization.
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.
Willingness to travel within North and South America (up to 40%).
Benefits Baxter offers comprehensive compensation and benefits packages for eligible roles. Health and wellness benefits include medical and dental coverage from day one, insurance coverage for basic life, accident, short‑term and long‑term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) and the 401(k) Retirement Savings Plan (RSP). Flexible Spending Accounts, educational assistance programs, and time‑off benefits such as paid holidays, paid time off, family and medical leaves of absence, and paid parental leave are also provided. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
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.
Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please let us know.
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. To protect yourself, review our Recruitment Fraud Notice.
Compensation The estimated base salary for this position is $112,000‑$154,000 annually. The position may also be eligible for discretionary bonuses and long‑term incentive.
Eligibility Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
#J-18808-Ljbffr
Supplier Quality Assurance Lead (Injection Molding Expert)
role at
Baxter International Inc.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our mission is to Save and Sustain Lives, and every individual is empowered to take ownership and make a meaningful impact. This is where your work makes a difference.
Role Summary As a Supplier Quality Assurance Lead you will work in a high‑visibility role to ensure that Baxter’s suppliers continue to enable our mission by providing high‑quality, safe, and effective products. You will collaborate with our Americas Raw Materials suppliers throughout their lifecycle from onboarding, maintenance, performance review, audits, and quality development.
Responsibilities
Improve/develop quality systems at selected suppliers for QMS and product quality improvement.
Execute SCAR management, ensuring effective and timely closure and review/risk assessment of supplier quality notifications and their escalation to SCARs and NCR where needed.
Collect, trend, and report supplier performance metrics.
Manage and oversee Supplier CAPA, including root cause identification and effective and timely closure.
Develop and/or deliver training and process improvement to internal teams and suppliers.
Perform qualification of component and medical device combination 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 and procedures.
Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes.
Coordinate acquisition or divestiture duties with the facility, develop/execute/complete associated protocols, and ensure all requirements are met and the facility is live or divested in the GSQ TrackWise database.
Support Manufacturing, Regulatory, Quality and Purchasing organization for third‑party supplier related activities.
Qualifications
Bachelor’s degree in life sciences or engineering.
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/Quality experience is preferred. Experience with other commodities relevant to medical devices or pharmaceuticals may also be considered.
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.
Experience with data analysis and reporting using basic Excel toolkit and advanced statistical / process packages such as Minitab or Visio and PowerPoint.
Knowledge of medical device regulations, e.g., ISO 13485, FDA cGMP, other global or regional equivalent.
Working knowledge of US and International cGMP.
Experience in Product/process development and/or supplier quality improvement.
Injection molding and device manufacturing experience.
SQA with technical background, good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, 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 about current and possible future policies, practices, trends, technology, and information affecting the industry, business and organization.
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.
Willingness to travel within North and South America (up to 40%).
Benefits Baxter offers comprehensive compensation and benefits packages for eligible roles. Health and wellness benefits include medical and dental coverage from day one, insurance coverage for basic life, accident, short‑term and long‑term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) and the 401(k) Retirement Savings Plan (RSP). Flexible Spending Accounts, educational assistance programs, and time‑off benefits such as paid holidays, paid time off, family and medical leaves of absence, and paid parental leave are also provided. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
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.
Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please let us know.
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. To protect yourself, review our Recruitment Fraud Notice.
Compensation The estimated base salary for this position is $112,000‑$154,000 annually. The position may also be eligible for discretionary bonuses and long‑term incentive.
Eligibility Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
#J-18808-Ljbffr