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Senior Supplier Quality Engineer

Location
West Menlo Park, California
Posted
23 Sep 2022

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. 

Summary

This position is responsible for supplier evaluation, qualification, and maintenance activities to support medical device existing and new manufacturing processes. This role will work with suppliers to investigate and resolve quality issues.  This position interfaces with Division and/or Corporate functions to deploy supplier quality related programs and initiatives. 

Essential Duties and Responsibilities

The Senior Supplier Quality Engineer is responsible for supplier evaluation, qualification, and maintenance activities to support medical device existing and new manufacturing processes. This role will work with suppliers to investigate and resolve quality issues.  This position interfaces with Business Unit and Corporate internal business partners to deploy supplier quality related programs and initiatives. 

  • Responsible for supplier quality system activities including supplier qualification/evaluation, SCAR investigations, assessment of supplier Notifications of Change, and supplier audits
  • Support qualification of new suppliers and materials/services for product launches and processes/projects to ensure completion of project milestones
  • Lead/Assist with investigations related to raw materials/components.  Work with suppliers to ensure thorough investigations and root cause analysis and monitor effectiveness of corrective actions
  • With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project.  This includes constructing detailed, accurate project schedules, interfacing with Technical Operations, Manufacturing, Logistics, Quality Control, Quality Operations, Regulatory Affairs and Project Management to assure successful project executions
  • Work with suppliers to apply process capability studies and understand and evaluate material manufacturing processes
  • Employ appropriate techniques and methods to successfully and independently execute/support material qualification projects.  Make technical recommendations regarding material qualification projects.  Identify opportunities for improving existing raw material quality and impact on the manufacturing processes by using tools such as FMEA, SPC, Design of Experiments, etc.  Develop appropriate raw material specifications with critical to quality characteristics
  • May be assigned other duties, as needed
  • Travel to supplier sites may be required

Qualifications

  • Strong interpersonal skills and great attention to details are necessary.
  • Must have strong technical understanding of medical device and/or biologics regulatory requirements
  • Must be a strong team player with good problem solving, and good verbal and written communication skills.
  • Must be able to handle multiple projects concurrently and work effectively and efficiently with a cross-functional team
  • Display a solid understanding of theories/practices utilized by other disciplines outside of primary area of expertise
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.  Demonstrated success in delivering results on technical challenges
  • Ability to develop and present a course of action with minimal assistance using both written and verbal methods
  • Ability to prioritize multiple tasks and work in a fast-paced environment with accountability for deadlines
  • Preferred: Familiarity with injection-molded components and process validation.
  • Preferred: Knowledge of statistical analysis tools

Education and/or Experience

  • BS in Engineering
  • Minimum of 3 years of experience in Quality related function or Supplier Quality with a medical device/Pharma company or other similarly regulated industry. Experience with applicable medical device (21CFR820, ISO13485, CMDR, MDD) and/or biologics regulations highly desirable

Physical Demands

  • Regular attendance is necessary to perform the essential functions of the job.
  • Light work, frequent lifting up to 50 lbs.; frequent standing/walking.

Working Environment

  • Minimal to moderate travel required.
  • Normal office working conditions: computer, phone, files, fax, copier.

#IND-USOPS

#LI-LH1

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 
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 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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Details

  • Job Reference: 719478966-2
  • Date Posted: 23 September 2022
  • Recruiter: Baxter
  • Location: West Menlo Park, California
  • Salary: On Application