Job Information
Baxter Healthcare Corporation Sterilization Quality Engineer /JR - 147030 in Cleveland, Mississippi
This Position is for a Sterilization Quality Engineer with a work location in Cleveland, MS.
This position is a key role in the Quality organization. Primary areas of responsibility will be on-site and off-site sterilization and managing subordinates in these areas. This role is responsible for carrying out duties in accordance with the organization's policies and applicable laws.
Responsibilities will include implementation of the quality systems, processes and procedures in the sterilization departments. This role is responsible for training employees; planning, assigning, directing and driving work; and resolving problems.
Additional focus will be on implementing continuous improvement, supporting equipment/system upgrades and new equipment/systems. Multi-functional collaboration will be involved in this role as well.
What you'll be doing
Responsible for the scheduling of sterilization services in house and with Contract Sterilizers.
Responsible for sterilization qualification and requalification scheduling and execution of studies.
Responsible for scheduling and execution of temperature mapping studies across the facility.
Must perform process validation, process capability, and process control studies for assigned areas.
Must drive quality/manufacturing projects applying Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.
Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technology.
Analyze and assess current systems to assure regulatory compliance.
Facilitate the validation status of key process equipment.
Plan and prioritize different projects to ensure completion within the target dates.
Perform failure investigations and track follow-up corrective actions as indicated.
Must assist in the identification and development of process improvement projects including automation and computerization.
Responsible for ensuring FDA regulations are met for system upgrades/replacements.
Ability to function optimally as a member of a team.
Ability to communicate optimally in written and verbal form.
Responsible for Specification/SOP compliance for sterilization processes (EO, gamma, steam)
Evaluate and assist in ways to improve supplier and plant processing characteristics to improve the quality and cost of sterilized products.
Support and assist in activities to assure products' sterility is maintained.
Responsible for Quality management activities in supporting the plant unreleased and released sterilized products.
Must perform other duties and responsibilities as determined by supervision/management.
Must have knowledge of both plant and departmental environmental health and safety regulations and align with said regulations accordingly.
Some Travel required.
What you'll bring
BS degree in Engineering Subject area and 3-5 years related experience
Leadership skills.
Ability to work independently
Strong team leadership skills
Ability to work with a diversified multi-functional team across within and outside the facility.
Strong written and communication skills
Logical thought process and consistently exercise discretion and judgment
Self-motivated and work well without direct supervision.
Ability to quickly learn and understand applications.
Meet visual acuity requirements as documented in the Baxter Cleveland Visual Acuity Procedure CL-01-01-037.
Ability to lift to 10 pounds
Ability to sit, stand and/or walk for long periods of time
Ability to reach above the shoulder
Ability to bend/stoop
Knowledge of applications such as Wonderware, Allen-Bradley PLC, Microsoft Project preferred.
Sterility Assurance or Pharmaceutical industry experience desired
Previous experience desired with EO, Gamma Irradiation, and/or Steam Sterilization
ASQ Certification (CQE or CSQ ), Green Belt Certification, Black Belt Certification or equivalent desired.
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.