QA Eng Manager

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

This is where your work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Your Role at Baxter

This is where your creativity addresses challenges!

As QA Engineering Lead you provide Quality Assurance leadership and oversight for engineering-related quality processes across medical device solutions and pharmaceutical manufacturing sites. This role ensures that validation change control metrology utilities/facilities and operational excellence activities are executed in compliance with applicable medical device pharmaceutical and combination-product regulations and standards while enabling efficient reliable and scalable operations. The role partners closely with Engineering Manufacturing Operations IT Regulatory Affairs and Quality teams to ensure that technical changes systems and infrastructure remain compliant well controlled and aligned with business objectives and patient safety requirements across regulated environments.

What youll be doing

• Provide QA oversight and governance for validation change control and lifecycle management of equipment processes utilities facilities and computerized systems across medical device and pharmaceutical operations ensuring compliance with global regulatory standards (FDA ISO EU GMP ICH GAMP).
• Review and approve validation qualification calibration and change control documentation ensuring systems remain in a state of control and risks to product quality patient safety and compliance are effectively managed.
• Support new product introductions technology transfers automation digital solutions and facility expansions partnering with Engineering and Operations to embed Quality principles into continuous improvement initiatives.
• Oversee critical utilities facilities and metrology programs ensuring systems are qualified maintained monitored and inspectionready with appropriate mitigation of deviations and outoftolerance conditions.
• Act as a key Quality partner during audits and inspections drive standardization and simplification of QA Engineering processes provide coaching and guidance to technical teams and influence quality outcomes in a matrixed environment.

What youll bring

• Bachelors degree in Engineering Pharmacists with postgraduate qualifications in Engineering and relevant experience in Quality Validation and regulated environments or similar experience.
• 7 years of experience in Quality Engineering Validation or Manufacturing within regulated medical device and/or pharmaceutical environments
• Strong working knowledge of validation/CSV change control utilities and facilities qualification and quality systems
• Experience supporting regulatory inspections and audits

Preferred

• Experience with FDA QMSR / 21 CFR 820 ISOCFR 210/211 EU GMP ICH Q7 and GAMP 5
• Experience supporting combination products or multi-platform manufacturing sites
• Familiarity with lean continuous improvement or business excellence systems in regulated environments

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.

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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