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Senior Principal Quality Engineer

Employer
BAXTER
Location
Salem
Salary
Competitive

View more

Industry
Healthcare
Role
Engineer
Job Type
Long-Term
Hours
Full Time

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 will work as a member of one or more project teams by being engaged in sustaining products and/or new product development for medical device systems. Provides Quality Engineering leadership to product development programs and projects. This individual will work closely with product engineering to ensure robust requirements, successful design, development, verification and validation testing, design transfer, change control management and will also provide support to medical product sustaining engineering.

Essential Duties and Responsibilities

  • Provide quality oversight and guidance to project teams by assuring that Quality Engineering principles are utilized to develop and enhance products that are robust, safe and effective
  • Ensure compliance to applicable Baxter policy, procedures and regulations
  • Provide direction and critical reviews for Development Planning, Design Inputs, Design verification and Validation, Peer Technical and Design Reviews, Risk Management and Labeling review
  • Interface with Baxter plant, external partners and corporate groups to transfer new and improved products
  • Develop, review and approve DHF, DMR, risk management, verification, validation and other product development documents
  • Develop and revise procedures to support product development programs and projects
  • Provide training / guidance to project personnel regarding the appropriate application of design, statistical and analytical tools
  • Lead corrective and preventive action related activities as appropriate
  • Identify areas for improving regulatory compliance and continuous improvement opportunities for products and processes
  • Excellent problem solving skills and the ability to teach others
  • Perform other duties as assigned

Qualifications

  • Must have the ability to apply engineering and scientific knowledge and independent judgment to technically support the Quality function on a global basis
  • Ability to influence team on courses of action with minimal assistance using both written and verbal methods
  • Effectively operate in and may facilitate cross-functional teams
  • Must be able to provide solutions that reflect understanding business objectives and cost implications along with quality and regulatory requirements
  • Knowledge of the global Regulatory and Quality requirements for medical devices including ISO 13485, FDA Quality Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR and other applicable international regulations
  • Good project management and organizational skills
  • Solid understanding of problem solving and statistical analysis tools
  • Excellent verbal and written communication skills

Education and Experience

  • BS Engineering and 8 or more years relevant experience
  • Relevant experience supporting products in a regulated environment is required. At least 3 years of Quality Engineering experience is preferred.
  • ASQ and/or Six Sigma certification preferred
  • Demonstrated success in delivering results on several technical challenges

#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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