Principal Quality Engineer
Location: Saint Paul
Posted on: August 7, 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. SummaryProvide
Quality Leadership and support to the value stream product teams
for biological and/or mechanical medical devices. Ensure proper
product design and manufacturing process design and execution for
such devices.Essential Duties and Responsibilities
- Participate on product development teams to improve current
product and transfer of the design to manufacturing. Participate in
risk management activities (quality planning, product and process
risk assessment and risk management), review and approval of
process and product validation protocols and reports, review
component qualifications, and test method
- Lead site initiatives to implement validation programs,
inspection programs, regulatory compliance programs.
- Set statistically valid inspection requirements, including
identifying test methods and sampling plans and assist with
designing inspection fixtures. Assure measurement systems are
capable using MSA, when applicable.
- Partner with manufacturing on quality related process
improvement projects, lean manufacturing projects, and equipment
qualification/validation, through review and approval of protocols
- Investigate, analyze, review and report on Product Complaints
- Participate on and lead process improvement teams to implement
quality improvement activities using Lean, and Six-Sigma
- Be the site lead to implement systems and processes for global
alignment Lead or participate in Corrective and Preventive Actions
- Ensure alignment of site processes to business-wide
- Manages coaching, training and development of
- Job experience or advanced training and demonstrated
proficiency in total quality management, statistical methods,
quality tools, root cause analysis / resolution, risk analysis,
SPC, MSA, and design of experiments.
- Experience in new product development, materials science, and
- Excellent oral and written communication skills.
- Strong problem solving, technical writing, organizational,
leadership, and interpersonal skills.
- Successful track record of leading large or complex projects
and diverse teams.
- Working knowledge of FDA Quality System Regulations, ISO-13485,
- Proficient MS Office skills including MS-Project and
- Must have the ability to read/interpret design prints.
- B.S. degree in Engineering, or related scientific discipline.
ASQ CQE certification required if 4 year degree is not in
- 6-8 years of experience in quality and/or product
- Advanced technical degree preferred.
- ASQ Certification in Quality Engineering and/or Auditing is
- Prior supervisory experience.
- Microbiology and sterilization validation experience highly
- Experience with biological products and/ or chemical processing
- Previous Quality Auditing experience is desirable Equal
Employment OpportunityBaxter 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 . 048661
Keywords: BAXTER, St. Paul , Principal Quality Engineer, Engineering , Saint Paul, Minnesota
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