Spec, Quality Supplier
Baxter · Monterrey, Nuevo León, United States
About The Role
This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
Your role at Baxter
You as a Spec. Supplier Quality Engineer (SQE) provides sophisticated leadership in handling supplier quality. They drive continuous improvement of supplier performance to ensure the highest standards of product quality, compliance, and reliability.
What you will be doing
- Lead resolution of supplier-related quality issues, including audit findings and systemic nonconformances (SCARs), ensuring detailed identification of underlying problems and effective corrective actions.
- Review, evaluate, and approve supplier change requests (e.g., process changes, site transfers), ensuring risks are accurately assessed and mitigated.
- Build and apply supplier risk management strategies, ensuring continuity of supply and compliance with regulatory and quality requirements.
- Establish and maintain positive relationships with key suppliers, driving continuous improvement in quality, delivery, and performance.
- Serve as the Supplier Quality representative during internal and external audits, ensuring supplier-related compliance readiness and effective audit outcomes.
- Develop, implement, and maintain the Supplier Audit Program, including planning, conducting, and follow-up of supplier audits.
- Monitor, analyze, and handle supplier performance metrics (scorecards), driving accountability and improvement actions.
- Support qualification and validation activities for supplier-related changes, including part qualification and engineering change management.
- Lead structured problem-solving initiatives targeting critical supplier quality issues (e.g., Top Supplier Issues), ensuring sustainable solutions.
- Provide quality input and insights for Supplier Business Reviews and participate in governance forums related to Supplier Quality Assurance.
- Participate in Design for Excellence (DFx) reviews with suppliers to ensure manufacturability and quality are built into product and process design.
- Conduct periodic supplier re-evaluations, ensuring ongoing compliance and performance alignment with company standards.
- Drive and support process improvement initiatives (Process Excellence) within the supplier base.
- Develop and implement risk mitigation plans for provisional or high-risk suppliers.
- Ensure supplier quality agreements and terms are defined, current, and successfully implemented.
What will you bring?
Required
- Bachelor’s degree in engineering or related technical field required.
- Minimum of 3–5 years of experience in supplier quality, manufacturing, or quality engineering within a regulated industry (medical device preferred).
- Proven understanding of ISO 13485, ISO 9001, and applicable regulatory requirements.
- Experience with supplier audits, quality systems (QMS), and continuous improvement methodologies is helpful.
Additional Skills / Special Training / Technical Skills Required
Required
- Strong analytical and problem-solving skills, including structured methodologies (e.g., root cause analysis, risk assessment).
- Validated background in managing supplier quality, conducting audits, and ensuring regulatory compliance.
- Effective communication and influencing skills, with the ability to collaborate across all interpersonal levels and with external partners.
- Proven track record to lead multiple priorities and get results in a sophisticated, regulated environment.
- Knowledge of manufacturing processes, supplier development, and quality systems.
- High level of accountability, integrity, and commitment to quality and compliance.
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, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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 .
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