Principal Quality Engineer - Advanced Surgery

BAXTER

Deerfield, IL 60015

Posted 1 month 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. 

The Senior Principal Quality Engineer applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products or Quality processes. The person in this role plans, executes and functionally directs important engineering assignments, which require independent judgment. Design, lead and perform experiments using sound scientific principles.

Essential Duties and Responsibilities

  • Applies state of the art techniques in the area of expertise to develop new or improved products and processes
  • May lead a large scale program or several small projects with complex features
  • Independently plans, schedules and leads cross-functional team in detailed phases of the Quality work in a project
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvement
  • Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
  • Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
  • Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
  • Take lead role in NCR/CAPA activities such as investigation, implementation, or verification of effectiveness
  • Support risk management activities as they relate to product and post market surveillance.
  • Provide product quality support on new product development, risk management, design transfer and sustaining engineering core team
  • Work collaboratively with RD to develop Product Design Requirement and Test Methods for successful Design Verification and Validation
  • Defend/support product design history file (DHF) in internal and external audits
  • Provide PQ support to 510(k) submission, product launches, product recalls/field actions, NCRs and CAPA investigations

Qualifications

  • Proficient in relevant products or process development processes (i.e. NPD and sustaining-life cycle management)
  • Must have experience with creating/managing Design History File (DHF) and Risk Management File (RMF)
  • Must have experience or advanced training and demonstrate proficiency (e.g. computer-aided design, total quality management, statistical methods, problem analysis and resolution, materials science, design of experiments, software development)
  • Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls
  • Successful track record of managing wide-ranging activities within the business unit
  • Strong interpersonal/communication/influencing/negotiation skills
  • Good project management skills
  • Recognized as a technical expert by peers and other personnel within the business unit
  • Extensive cross-functional team experience, including technical and non-technical work
  • Ability to organize and present technical and project mgt. overviews without assistance
  • Strong knowledge of FDA Regulations (e.g. 21 CFR Part 820), Application of Good Laboratory Practices, Application of Good Manufacturing Practices, ISO (e.g. ISO13485 and ISO14971) and other applicable standards (e.g. IEC60601 and IEC62304 electromechanical medical device) and ISO 22442 (Med Devices utilizing animal tissues) and regulatory requirements (e.g., EU MDD and MDR)

Education and Experience

  • B.S. degree in Engineering
  • Minimum of 5 years’ experience in Quality, Manufacturing, Engineering or related field
  • Demonstrated success in delivering results on several technical/product/Quality challenges
  • ASQ and/or Six Sigma Blackbelt Certification preferred
  • Product development experience with electromechanical or biological tissue products preferred

#LI-BAXGEN

#IND-USOPS

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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