Senior 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 Engineer, you will collaborate with your team to develop and maintain Peritoneal Dialysis (PD) electro-mechanical (EM) medical device products. You will provide Quality Engineering leadership to ensure successful design, testing, and transfer of EM medical products.

This individual will work closely with product engineering to ensure robust requirements, successful design, development, verification and validation testing, design transfer, change control management and will also provide support to medical product sustaining engineering.

Within Quality, every role makes a difference. Products that Vantive makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Vantive is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

The Renal Peritoneal Dialysis (PD) Product Quality Engineering Team is looking for a dedicated Senior Quality Engineer to support quality engineering product support activities.

What you'll be doing

• Provide quality oversight and guidance to project teams by assuring that Quality Engineering principles are utilized to develop and enhance products that are robust, safe and effective
• Develop, review and approve DHF, DMR, risk management, verification, validation and other product development documents
• Ensure compliance to applicable Vantive policy, procedures and regulations
• Provide direction and critical reviews for Development Planning, Design Inputs, Design verification and Validation, Peer Technical and Design Reviews, Risk Management and Labeling review
• Interface with Vantive plant, external partners and corporate groups to transfer new and improved products
• Evaluate all relevant operational data, reports, statistics, and documentation related to manufacturing process and product performance and product quality, to generate proactive and timely actions when needed to address a quality issue or improve a process.
• Provide training / guidance to project personnel regarding the appropriate application of design, statistical and analytical tools
• Lead CAPA related activities as appropriate
• Monitor and report on CAPA KPIs at monthly governance meetings
• Identify areas for improving regulatory compliance and continuous improvement opportunities for products and processes
• Use Microsoft Excel to compile and create trending information for input into the sustaining products organization from various quality inputs (including but not limited to: nonconformance, FCA, complaints, MDR, etc.)

• Prepare and/or support monthly PQDR (product quality data reports) based on information analysis
• Support both internal and external audits

What you'll bring

• Bachelor's degree in Engineering (Biomedical, Mechanical or Electrical preferred)
• At least 3 or more years of experience in Quality, Engineering or Manufacturing or related field
• Relevant experience supporting products in a regulated environment is required. At least 1 year of Quality Engineering experience is preferred.
• Knowledge of the global Regulatory and Quality requirements for medical devices including ISO 13485, FDA Quality Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR and other applicable international regulations
• Prior experience with problem-solving and analytical skills
• Good communication and interpersonal abilities
• Ability to work collaboratively in a global and team-oriented environment
• Good technical skills (e.g. spreadsheet, databases and online research)

Nice to have:

• Green Belt or Black Belt Certification desired

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 $88,000-110,000.00 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.

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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