Supplier Quality Engineer
Irvine, CA 
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Posted 11 days ago
Job Description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Your Role at Baxter

The Supplier Quality Engineer (SQE) will work closely with suppliers, purchasing, engineering and quality functions to support projects that affect supplier selection, assessment, qualification, performance, productivity, and effectiveness. The SQE will investigate, track and analyze data, and implement corrective and preventative actions to ensure supplier meets both site and corporate supplier quality management program requirements, as well as required regulations.

In addition, this role ensures compliance with GMP and all applicable standards, while supporting the product/process through process optimization, risk management, validation, defect analysis and prevention, exception and project management, and technical evaluations. The job contributes engineering/technical expertise through the Quality function to the manufacturing facility. The job requires basic engineering skills, statistical/six sigma skills, numerical analysis techniques and implementation skills for process improvement.

What you'll be doing

  • Reviews current manufacturing specifications and identify materials needed for production.

  • Research, sources, and assess vendors to supply the necessary materials.

  • Ensures supplier compliance to current site procedures and processes.

  • Leads initiatives to ensure supplier qualification requirements are developed and met.

  • Identifies and resolves issues from suppliers.

  • Visits vendor facilities and observes the manufacturing environment to review and assess their procedures.

  • Reviews incoming supplies and products from vendors to check for defects and ensure quality.

  • Conducts tests and assessments on products to identify quality issues.

  • Maintains detailed reports on supplier quality, including defect rates and areas that result in issues.

  • Provides technical advice and guidance to suppliers to reduce defect rates.

  • Serves as a liaison between our company's senior management and the vendors to identify quality issues and determine solutions.

  • Supports the manufacturing plant through implementation of process improvements.

  • Manages small projects (both new and improvement) to include cost, implement

  • Assists in evaluation of customer complaints, risk management and technical summaries.

  • Assists in evaluation of supplier product/process changes.

  • Assures compliance of manufacturing and quality control operations with respect to corporate specifications, SOP's, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485, and other applicable standards and regulations.

  • Supports and may own execution of CAPA investigations with use of DMAIC process and technical writing skills.

  • ation, and validation.

  • Provides statistical assistance to Quality and Production.

  • Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.

  • Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.

  • Composes protocols, final reports, studies, experiments, and general information reports for use by management.

  • Leads/coordinates validation efforts of new equipment and changes to existing equipment.

What you'll bring

  • BS degree in Engineering preferred, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience.

  • Minimum 2 years of experience in supplier quality in regulated manufacturing environment

  • Experience with quality systems and quality assurance/control

  • Ability to prioritize, plan and evaluate deliverables to ensure supplier compliance.

  • Strong technical writing and investigation skills required.

  • Understanding and knowledge of various international standards relating to a variety of topics, as needed (i.e. ASTM, ASRAE, ANSI, AAMI, ISO standards applicable to scope of work) .

  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.

  • Familiarity with MINITAB.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $72,000 - $99,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonus. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

#LI-KV1

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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
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Pay Transparency Policy

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 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 .

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Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
2+ years
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