Senior Quality Engineer

Job Description

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 :

The Senior Quality Engineer is responsible for supporting and sustaining Medical Device Quality Technology and Engineering activities related to design control and post-market product support for therapeutics products.

What you'll be doing :

Prepare and manage the internal audit schedule for Vantive Twin Cities

Assist in performing internal audits for the Medical Device R&D organizations as well as Drug Product R&D organizations

Prepare internal communications related to the audit including final reports.

Perform and host internal audits in conjunction with the Quality Manager

Ensure site compliance with local and global Quality Management System Procedures.

Perform quality-related functions for post market activities such as Nonconformance Investigation and Corrective and Preventive Action (CAPA) Management.

Consult with site personnel as QMS Subject Matter Expert to advise on QMS requirements.

Assist in preparing and hosting external audits with regulatory authorities.

Review and approve design inputs, outputs, verifications, validations, and design transfers in accordance with QMS requirements.

Assist in decision making for process and product improvement efforts.

Write, review, analyze and revise Local QMS documentation.

What you'll bring :

Bachelor's Degree in related field and 3+ years of relevant experience in the medical device industry or similarly regulated industry. Or substitute 7 years of relevant experience in the medical device industry or similarly regulated industry.

Minimum 2 years of experience performing internal or external audit activities.

Demonstrate understanding in the areas of Quality Engineering and worldwide Quality System standards and regulations.

Ability to work under deadlines and changing priorities with minimal supervision.

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

Demonstrated ability to perform within project and investigational environments.

Nice to have :

B.S. in Engineering or Science Discipline

Formal Audit training or certification

American Society for Quality Certification (e.g., CQE, CQA, etc.) and / or Six Sigma certification highly preferred.

Demonstrated assertiveness and ability to represent the Quality function in various roles in support of R&D engineering activities including product support and lifecycle management.

Experience / understanding of Risk Management techniques and principles.

Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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 $80,000 to $95,000 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. 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.

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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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