Quality Systems Engineer

Baxter

Castlebar, Co Mayo
Permanent
Full-time

23 days ago

Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.Quality Systems Engineer RoleEssential Skills and Responsibilities:

Responsibility for Castlebar/Swinford Internal Audit programme
Facilitation of external audits including Regulatory and Customer audits for Castlebar & Swinford sites.
Responsibility for the Supplier Quality Management programme for Castlebar & Swinford.

Expectations:

Responsible for preparation and maintenance of Internal audit schedule.
Issuing audit reports, tracking audits performed and communicating to all relevant Management & personnel on the status of audit performance and closure.
Responsibility for ensuring internal and global metrics are maintained.
Assessing and approving suppliers & performing inspections of Suppliers.
Be able to work both independently and also as part of a team
Excellent communication (verbal and written), presentation and project management skills
Excellent technical writing skills

Requirements:Knowledgeable on regulatory requirements such as EU GMPs and FDA 21CFRUnderstanding of local and corporate Quality Systems requirements.Quality Systems experience is desirable however, training will be provided.Degree in Science/Quality, or equivalent qualification.Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 .

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