Sr. Manager, Quality

Vantive; Plymouth (MN); On-site; USD 144,000 - 198,000; Full time

Benefits offered by this job

401(k) retirement plan

Paid holidays

Disability and life insurance

Job summary

Vantive seeks a Quality Management Representative (QMR) for its Twin Cities R&D multi-site campus. You will implement the Vantive Global Quality Management System and manage QMS documents for Quality, R&D, Regulatory, Facilities, across multiple sites.

You will lead PRRC, oversee VIP/MDDAP activities, train staff, manage NCR/CAPA and coordinate external inspections to ensure regulatory compliance and product quality.

Qualifications

• Bachelor-level engineering or science degree required.
• 8+ years in Quality/Manufacturing/Engineering with 3–4 years supervisory experience.
• Knowledge of global regulatory and quality requirements for medical devices; ISO 13485, FDA 21 CFR parts 7/11/803/806/810/820, ISO 14971, MDD 93/42/EEC, EU MDR 2017/745.
• Proven leadership of large global teams; strong verbal and written communication.
• Experience with multifunctional global teams and third-party development partners.
• Excellent problem solving, negotiation and influencing skills.

Responsibilities

• Quality Lead for PRRC responsibilities for legal manufacturing at Vantive Twin Cities sites.
• Oversee participation in FDA VIP via MDDAP program using CMMI.
• Lead and train multi-site personnel; ensure NCR/CAPA ownership and Trackwise access.
• Manage legal manufacturing quality responsibilities across sites and external manufacturers.
• Lead periodic management reviews to ensure QMS effectiveness.
• Ensure regulatory conformance for QMS activities and manufacturing oversight.
• Coordinate external regulatory inspections and audits as lead interface.
• Support MDDAP process as CMMI Practitioner/Professional.
• Oversee NCR/CAPA processes and internal quality assessments.
• Drive continuous improvement projects for quality, reliability and cost.
• Budget development and cross-location budget adherence.
• Coach and develop subordinates; manage quality budgets across sites.

Skills

Leadership

Regulatory knowledge

Analytical thinking

Communication

Education

B.S. in Engineering or Science

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:

Quality Management Representative (QMR) for Vantive's Twin Cities R&D multi-site campus across three physical facilities.

Implement the Vantive Global Quality Management System 9QMS) and manage local QMS documents including procedures for Quality, R&D, Regulatory, Facilities, etc. for multiple Vantive Twin Cities sites responsibility for results in terms of compliance and product quality.

What You'll be Doing:

• Quality Lead for Person Responsible for Regulatory Compliance (PRRC) for legal manufacturing responsibilities for Vantive Twin Cities sites. Provide technical and strategic input for regulatory decisions aligned with business strategy.
• Manage Vantive Twin Cities sites’ participation in the FDA’s Voluntary Improvement Program (VIP) through the Medical Device Discovery Appraisal Program (MDDAP) utilizing Capability Maturity Model Integration (CMMI).
• Oversee employee training and ensure multi-site personnel are qualified for their position. Actively train employees to be qualified NCR/CAPA owners, Change Control (CCM) Record Owners, and site administrator for Trackwise 8 system access.
• Identify, implement and manage the legal manufacturing quality responsibilities and procedures for the products manufactured at other sites including external manufacturers.
• Lead periodic management reviews ensuring suitability and effectiveness of the Quality Management System (QMS).
• Understand and assure conformance to regulations with respect to QMS activities and legal manufacturing oversite.
• Arrange and host external regulatory inspections and audits acting as the lead interface with regulators and auditors.
• Support other Vantive sites via on-site appraisals through the MDDAP process as a CMMI Practitioner / Professional.
• Lead the Non-conformance (NCR) and Corrective/Preventive Action (CAPA) processes for the Vantive Twin Cities sites as both SME (subject matter expert) and Approver and ensure compliance with QMS procedures.
• Lead periodic internal quality assessments or audits of functions at the site to analyze compliance and assess risk.
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
• Develops budget for a section or department and ensures adherence to the budget.
• Manages the coaching, training and development of subordinates.
• Manage Quality budget across multiple physical locations.

What You'll Bring:

• B.S. in Engineering or Science
• 8+ years’ experience in Quality, Manufacturing, Engineering or related field which should include 3-4 years of supervisory experience.
• Knowledge of the global Regulatory and Quality requirements for the manufacture and marketing of medical devices; knowledge of ISO 13485, FDA 21 CFR Part 7, 11, 803, 806, 810, 820, ISO 14971, MDD 93/42/EEC and EU MDR 2017/745
• Strong leadership skills and demonstrated success in managing a large global team
• Strong analytical and problem-solving skills
• Strong verbal and written communication skills
• Success working with multifunctional, global teams and third-party development partners
• Strong interpersonal/communication/influencing/negotiation skills required
• Capable of analyzing and solving complex problems through innovative thought and experience

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 $144,000 to $198,000 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.

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