Principal Quality 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.

As a Principal Quality Engineer at Vantive, your work supplies directly to making a significant impact on others. It's ambitious work-and you're not on your own. Our teams collaborate multi-functionally and lead by influence. Whether guiding a team through a project or leading direct reports, our research and development team is responsible for influencing others to achieve results.

Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of collaboration and are natural leaders who are skilled at influencing others.

The Principal Quality Engineer will work as a member of one or more project teams by being engaged in sustaining products activities and new product development support according to the Product Development and Life Cycle Management process. Serve as the Quality Lead responsible for preparation and execution of the monthly Product Quality Data Review to assess and present post-market trending for the business segment. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. A functional understanding of FDA requirements, ISO standards and the general QMS is required.

Essential Duties and Responsibilities

• Establish Quality metrics around product KPIs and present product post market performance / trending as the Quality Lead at the monthly Product Quality Data Review (PQDR) for the business segment. Then initiate necessary actions to drive product improvements / design changes to address unfavorable KPI trends and sustain product performance in the field.
• Work closely with product engineering to support NPD activities including Design & Development Plans, design inputs, outputs, verification, validation, and design transfer strategies according to the Product Development & Life Cycle Management (PDLM) process and based on the established Quality Plan, while maintaining necessary risk control measures.
• Support post market activities for electromechanical products including MOH (Ministry of Health) complaint inquiries, risk assessments, etc.
• Manage activities of self and support others in achieving defined quality goals in an efficient, accurate and timely manner.
• Provide support to product sustaining engineering specifically through supporting risk and change control management execution.
• Provide post market surveillance support and data including complaint investigation, complaint trending and complaint rate of new / emerging issues reported from the field to support Event Based Risk Reviews, NCR / CAPA and FA, as necessary.
• Provide quality input to DHF and risk remediation activities.
• Provide support to project personnel regarding the appropriate application of design, statistical and analytical tools.
• Support audit and compliance activities at the site.
• Assist in decision making for process improvement efforts.

Requirements

• Ability to engage management and other functions to influence decisions on courses of action with minimal assistance using both written and verbal methods.
• Demonstrate understanding and working knowledge in the areas of worldwide Quality System standards and regulations, including FDA Regulations and Application of Good Manufacturing Practices.
• Prior experience in reviewing and approving software verification, system validation and labeling verification test cases, test runs and relevant defects using the HP-ALM Application to support NPD is desirable.
• Ability to perform data analysis in Excel / Minitab and establish meaningful product related Quality metrics, for presenting them within the monthly Product Quality Data Reviews (PQDR).
• Ability to work under deadlines and changing priorities with minimal supervision.
• Able to manage multiple projects and/or responsibilities simultaneously
• Must be a team player with excellent verbal and written communication skills to work cross-functionally in a highly matrixed organizational environment.
• Strong analytical and problem-solving skills.
• Must be proficient with Microsoft Office and other data collection/analysis programs (e.g. Minitab, Excel).

Education and Experience

• B.S Degree in engineering
• Requires minimum 8 years of experience in Quality, Manufacturing, Engineering in Medical Device industry. Cross-industry experience a plus. (e.g., automotive, aerospace, combination products).
• Medical Device regulatory experience preferred. (FDA, EU MDR, etc.).
• Excel proficiency required.

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 $104-143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. 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.

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive 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 Recruitment Fraud Notice.