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. 

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 performed in accordance with FDA guidelines and meet the overall business priorities and schedules.

Your Team

Cleveland’s technology and automation are innovative. 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.

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 follow 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

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