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Head of Quality and Risk

3 months ago

Cleveland MS, United States Baxter Full time

At Baxter, we are deeply connected by our mission. 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.

About Baxter’s Cleveland, MS Facility:
Cleveland’s technology and automation are cutting edge. 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. 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; 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.

Medical, Dental and Vision coverage
~160 hours of Paid Time Off and Paid Holidays
~Tuition Reimbursement


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.
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.
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.
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.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.

Bachelor degree in Microbiology, Biology, Chemistry or Engineering Required.
~7+ years experience in Quality, Manufacturing, Engineering or related field. Good project management skills.
~ 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. 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.


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