![](https://tbcdn.talentbrew.com/company/152/v4_0/img/ajd-hero-quality-sm.webp)
Quality Manager II - Validations and Risk Management
Descripción general
Aquí es donde usted marca la diferencia en la seguridad de nuestros pacientes. Como miembro del equipo de Calidad de Baxter, desempeñará un papel esencial en nuestra misión de salvar y sostener vidas. La calidad es importante durante todo el ciclo de vida del producto y trabaja en colaboración con todas las áreas de la organización. Debido a que Calidad afecta todo lo que hace Baxter, un rol en Calidad brinda muchas oportunidades de crecimiento, aprendizaje y una carrera exitosa que tiene un impacto diario en la vida de las personas.
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Apoyo a las padres
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Educación continua/ Desarrollo profesional
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Salud de los empleados y Beneficios de bienestar
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Tiempo libre pagado
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2 días al año para ser voluntario
Perfil de éxito
¿Qué hace que un miembro del equipo de calidad de Baxter sea exitoso? Revise algunos de los rasgos principales que estamos buscando y vea si su perfil se ajusta.
- Orientado al detalle
- Aprendiz continuo
- Valiente
- Colaborativo
- Pensador crítico
- Influyente
Quality Manager II - Validations and Risk Management
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
About Baxter’s Cleveland, MS Facility:
Cleveland’s technology and automation are cutting edge. It is the U.S. sole source for plastic pour bottles, glass IV, and various reconstitution devices. This facility has a number of major product lines with a diverse array of automated manufacturing technologies ranging from bottle solution filling, injection molding, tubing extrusion, and device assembly. Our Cleveland plant has been an integral part of Baxter for over 60 years. The work is challenging and rewarding, as Baxter offers competitive compensation and benefits. Baxter encourages and values every employee and believes that all can make a contribution to advancing healthcare for patients; work to be proud of.
Your Role at Baxter:
This position is a key role in the Quality organization. Primary areas of responsibility will be leading activities related with Quality Engineering to provide technical support, and coordinate activities and projects of all documentation and quality operations for areas of responsibility, while assuring compliance with established standards. This key role is responsible for the overall direction, coordination, and evaluation of the unit.
This role is responsible for carrying out supervisory duties in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and resolving problems. Additional focus will be on implementing continuous improvement, handling equipment/system upgrades, and new equipment/systems. Cross-functional teamwork and project management will be involved in this role as well.
Responsibilities include hardware and software validation, integration of Six Sigma methodology/predictability into plant processes, paperless system implementation, process monitoring (SPC), data integrity requirements, and risk management oversight. The primary end results of this position is to assure all activities carried out through the site are properly executed in accordance with FDA guidelines and meet the overall business priorities and schedules.
What we offer from Day One
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Paid Parental Leave
Tuition Reimbursement
What you'll be doing:
Integrates the Six Sigma Process to Validations, Manufacturing and testing processes.
Assures compliance to all software and hardware validation requirements as well as equipment and software life cycle.
Assures compliance to data integrity initiatives and requirements.
Support timely validation efforts throughout quality operational areas.
Audits, creates, and implements changes to specifications and SOPs.
Plays an active role on quality management teams within the organization.
Supports implementation of VIP projects.
Supports implementation of paperless systems.
Supervise and support all area associates, assuring a teamwork environment.
Trains and integrates new engineers / associates
Oversees training and cross training of direct reports
Evaluates changes to systems and ensures proper process is followed for implementation.
Identify and implement improvements in laboratory testing methods and automation to upgrade laboratory efficiency, consistent with the lowest possible cost objectives of the business.
Leads team in qualification of identified upgrades.
Serves as a team leader to establish working teams.
Maintain good working knowledge of plant systems, processes, procedures, documentation, and products.
Manage and prioritize multiple tasks and projects.
Serve as plant quality software and validation facility contact with corporate or outside interests.
Develop and benchmark new technologies and methodologies for use in the facility.
Promote innovation in quality operational areas
Manage financial goals for departments.
Promote company security, industrial hygiene, cGMPs, and other policies established by the company.
Perform tasks independently with minimum supervision
Travel as needed to perform duties.
Ability to sit, stand and/or walk for long periods of time
Ability to reach above the shoulder
Ability to bend/stoop
Occasionally carry out duties of Quality Director or Operations Manager as needed
Must meet visual acuity requirements as documented in Baxter Cleveland Human Resources Procedure 1.04.
Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly.
Must perform other duties and responsibilities as determined by supervision/management.
What you will bring:
Bachelor degree in Microbiology, Biology, Chemistry or Engineering Required.
7+ years experience in Quality, Manufacturing, Engineering or related field. 5+ years of leadership experience.
Thorough knowledge of applicable procedures, specifications, regulations and standards.
Strong analytical and problem solving skills.
Ability to lead/supervise a team of employees.
Good communication and leadership skills.
Good interpersonal/communication/influencing/negotiation skills.
Good project management skills.
Six Sigma Black Belt Certification or industry standard equivalent is preferred.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, 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 $128,000 - $176,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than that 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.
#LI-BAXGEN
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter 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 Accommodations
Baxter 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.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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.
Dirección
![](http://tbcdn.talentbrew.com/company/152/v4_0/img/icon-location-pin.png)
Cleveland, MS 38732
United States of America Explorar esta ubicación
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