Engineer I, Quality

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.

Your role

This is where your expertise helps people

You are a problem solver. Sophisticated projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions.

Your talent is needed across a wide variety of industries. As a Quality Engineer Intern, you have a wide array of career choices, but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission.

Your team

We are a team of inquisitive individuals who embrace a collaborative environment to tackle sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment.

Our Quality Engineering Team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge.

When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking balanced with teamwork across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development.

The Quality Engineer I provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations.  This role ensures compliance with GMP/QSRs and all applicable standards related to product/process validation.  The job contributes engineering/technical expertise through the Quality Management function to the manufacturing facility.  he Quality Engineer is accountable for the validation process.  The job requires basic engineering skills, statistical/six sigma skills, numerical analysis techniques and implementation skills for process improvement. Knowledge of all validation phases is a must, from the conception of the project to the final signature.

What you'll be doing

• Leads or assists in developing and implementing new machines/processes and in improvements to existing methods. Requirements for new/improved machines/processes, including system specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Quality Engineer. This requires interfacing with Mountain Home Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions.
• Supports the manufacturing plant through implementation of process improvements.
• Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, VIP measurements and implements/drives change.
• Manage small projects (both new and improvement) to include cost, implementation, and validation.
• Provides statistical assistance to Quality and Production.
• Evaluates sampling plans with respect to current quality levels and test methods.
• Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
• Composes protocols, final reports, studies, experiments, and general information reports for use by management.
• Leads/coordinates validation efforts of new equipment and changes to existing equipment.
• Assist in evaluation of customer complaints, risk management and technical summaries.
• Assist in evaluation of supplier product/process changes.
• Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 820), Global Quality Manual (GQM), ISO 13485 (Current Revision), EN ISO 13485 (Current Revision), Canadian Medical Device Requirements (CMDR), MDD 93/42/EEC and other applicable standards and regulations.
• Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
• Support department execution of CAPA investigations with use of DMAIC process and technical writing skills.
• Excellent Technical writing skills, especially as it relates to the CAPA/Complaint process and the actions associated with those activities.
• Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
• Identifying and recording any problems relating to the product, process and quality system.
• Initiating and implementing solutions through designated channels.
• Establishing controls on a process and establishment of the verification/monitoring of such.
• Driving improvements into the production process, from conception to sustainable production methods.

What you'll bring

• BS degree in Engineering required.
• Strong technical writing and investigation skills required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  Minitab, POMs, Maximo etc.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires standing and walking for extended periods of time
• This is a safety-sensitive position for purposes of the Arkansas Medical Marijuana Amendment 

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is 72,000 to 108,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Learning / Doing (1)), Critical Systems (Learning / Doing (1)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Learning / Doing (1)), First Principles Thinking (Applying / Overseeing (2)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Learning / Doing (1)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0))

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future.  The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently.  The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive 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.

Know Your Rights: Workplace Discrimination is Illegal

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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