Quality Systems Engineer

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Quality Systems Engineer Role

Essential 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 21CFR

Understanding 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 Accommodation

Vantive 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. Form Link

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