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Engineer, Quality

Req #: JR - 054764 Location Marsa, Il-Marsa, Malta Job Category: Quality Control Date Posted: 11/19/2021

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Engineer, Quality

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 (optional)

  • The Quality Engineer - is responsible for supporting process developments and process changes to ensure that these are validated effectively in manufacturing. The incumbent is also responsible to support change controls / design changes and to ensure that these are transferred in manufacturing with the right set up to prevent manufacturing issues or complaints from the market.
  • The Quality Engineer is responsible for the test methods validations used in the Quality Control labs/manufacturing areas and to support the quality management team as required including the plant’s validation master plan and data integrity requirements.

Essential Duties and Responsibilities.  This section contains a list of five to eight primary responsibilities of the work.  The incumbent will perform other duties as assigned.

  • The Quality Engineer has the following main responsibilities =>
  • Qualification and Validation :
    • Support process developments and process changes to ensure that these are validated effectively in manufacturing by getting in depth knowledge of the processes and be a key role in PFMEA’s and their start up in manufacturing.
    • Support change controls / design changes and to ensure that these are transferred in manufacturing with the right set up to prevent manufacturing issues or complaints from the market. This will be done by close review of validation protocols and methodology for transfer in manufacturing, be a key player in FMEA’s and risk assessments to ensure that the change will not cause adverse issues in our manufacturing and to our customers.
    • Perform Validations as deemed necessary by his/her manager in relation to issues and improvement actions and test methods in area of responsibility.
    • Lead/co-ordinate the plant’s master validation plan.
    • Support in Data Integrity requirements

  • QC Duties and Responsibilities
    • The Qualification/Validation Engineer will lead/support test methods validation in the QC lab and ensure that these are done in a timely and compliant manner. He/she will support the Quality Manager in managing the lab and resolution of issues in the lab related to QC.
    • Ensure that all process under responsibilities comply with customer and regulatory requirements and Baxter Quality Management Systems standards.

  • New equipment/process in the lab:
    • To lead and validate new process, equipment in the lab.

  • Process Improvement
    • The Qualification/Validation Engineer is also responsible to work closely with the Process Improvement Engineer to ensure that process issues and relayed back to the validation team to ensure that these are solved.

  • General Duties and Responsibilities:
    • The incumbent is to perform duties in accordance to procedures aligned with ISO13485.
    • The incumbent is also responsible to ensure that all procedures related to his/her responsibilities are in line with TUV and Corporate requirements and that any corrective actions triggered by TUV/Corporate/Internal/Other audits are always implemented within the established time frames.
    • The incumbent is also responsible to consider the aspects of Environment Health and Safety procedures to ensure that all activities within his/her role will support EHS targets and will not jeopardize the health and safety of employees and environment.
    • The incumbent must also ensure that all documentation and practices related to his/her role are in compliance with good laboratory and documentation practices.
    • To support Manager in other responsibilities as may be required.

Qualifications.  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required. 

  N/A:  Intern or Co-op

Mechanical or Electrical Engineering Degree

Education and/or Experience.  Include the education and/or experience that is necessary to perform the job satisfactorily.

  N/A:  Intern or Co-op

Number of years of experience:  N/A

Field of expertise:                       Mechanical/Electrical Engineering

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] 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.

054764

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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