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.

Job Summary
The QA Validation and Metrology Engineer ensures that all validation methods, processes, facilities, equipment and supporting Computer systems are setup, validated and mantained according to applicable regulations and Vantive quality system.

Essential Duties and Responsibilities

• Assure that new or modified methods, processes, facilities, equipment, Computer Systems and Automated Excel Spreadsheets are designed and validated in compliance with the Standards and internal Vantive requirements, reviewing and approving related requirements and specifications;

• Support engineering department in defining and documenting validation strategies, preparing validation plans and reports;

• Support maintenance activites, by reviewing records from QA perspective when deemed necessary by Vantive quality system;

• Evaluate the change requests and compile the impact assessment for QA in case of Process and Design Change Controls; compile the execution and implementation phases ensuring they are conducted in compliance;

• Evaluate the impact of Vantive global QMS changes to local activity, contributing to the necessary improvements to local documentation;

• Manage calibrations of measuring equipment and test benches according to internal procedures; approve calibration certificates, calibration reports and metrological verification test reports issued both internally and by external entities;

• Review and approve local operating procedures required to ensure compliance of tools and processes;

• Support management, investigation and resolution of validation deviations or nonconformances.

Minimum requirements to apply for the job:

• Knowledge of Applicable Quality System requirements, in particular ISO 13485 and MDSAP;

• Knowledge of European Medical Device Directive 93/42/EEC for what may concern the design control and validation chapters;

• Knowledge of European Medical Device Regulation 2017/745 design control and validation chapters;

• Good knowledge of statistics and six sigma data analysis;

• Fluent English (written, spoken, read);

• Able to work in a team and Problem Solving Oriented;

• Good communication skills and able to liaise with the different functions involved; person capable to take ownership of assigned tasks from beginning to end.

Qualifications:

• University degree in Engineering or equivalent degree in scientific area;

• 3+ years of experience in design, test methods, equipment, facilities and computerized systems validation in the medical devices or pharmaceutical field.

• Knowledge of Gage R&R methodology for method validation will be a plus

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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