Quality Engineer

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.

Our Thetford site is recruiting for a Quality Engineer to join the team. We are looking to speak with candidates who have experience in Quality Assurance/Quality Compliance within a pharmaceutical or medical device environment. Having experience in root cause investigations would also be a huge advantage.

You will be joining a team of 7 consisting of Quality Engineers (Quality Assurance) reporting to the Quality Assurance Manager. This role is on site, working Monday-Friday 37.5 hours per week. There is flexibility on your start /finish time.

Continuous Improvement:

• Performing Continual improvement and compliance monitoring Gembas and other continuous

improvement initiatives.

• Assessing change controls

Governing of CAPA system

• Investigating and approving any Quality NCR. Owning and approving and Quality CAPA and

change control.

• Supporting and approving any non-QA NCR, CAPA, and change control. (In the role of approver:

advise on solutions.)

• Reviewing quality processes and procedures and advising on continuous improvement.

• Supporting and approval of non-QA related processes and procedures and advising on continuous

improvement.

Compliance:

• Keeping up to date and comply with Corporate and regulatory requirements, including EHS.

• Completing Quality Systems/QA commitments and communicating Quality Systems/QA issues in a

timely manner.

• Updating QA processes and procedures to be compliant with Corporate and regulatory

requirements.

• Collating and reviewing process performance/product quality data and disseminate the results to

support compliance and continuous improvement.

Production support:

• Performing QA tests, e.g. leak analysis.

• Advising on compliance with Corporate and regulatory requirements.

• Reviewing atypical events and complaints and initiating local holds.

• Reviewing processes and procedures and advising on Corporate and regulatory requirements.

• Supporting training, educating and coaching from a compliance and lean perspective.

Experience/Qualifications required:

• Qualified in a Scientific discipline
• Experience in the use of quality improvement and problem-solving tools and the interpretation of data
• Experience of process change control and validation
• Experience and/or knowledge of equipment calibration (desired but not essential)

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.

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