Quality Associate II

Baxter•Cleveland, OH

1d•Onsite

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Requirements

Ability to function effectively as a member of a team.
Ability to communicate effectively in written and verbal form.
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.
Must meet visual acuity requirements as documented in Baxter Cleveland Human Resources Procedure 1.04.
Bachelor’s degree in Microbiology, Biology, Chemistry or Engineering required.
Good knowledge of quality systems and procedures.
FDA manufacturing required.

Nice To Haves

Six Sigma Green Belt Certification or industry standard equivalent is preferred.
Lean Manufacturing skills and experience are preferred.

Responsibilities

Implementation of the quality systems, processes and procedures in the Devices departments.
Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and resolving problems.
Implementing continuous improvement, supporting equipment/system upgrades and new equipment/systems.
Cross-functional teamwork.
Implementing, maintaining, and improving the quality systems, processes and procedures in the Devices departments.
Manage and support all area technicians, assuring a teamwork environment.
Oversee training and cross training of technicians.
Train and integrate new associates.
Supporting process validation, process capability, and process control studies for assigned areas.
Performing customer complaint investigation activities (defect/failure analysis) on product as required.
Conducting nonconformance investigations and implementing corrective actions for product/process defects or failures.
Trending key quality performance metrics for the Devices departments.
Making independent decisions regarding product conformance and handle issues as they arise.
Communicating activities and occurrences from the shift to appropriate persons in an organized and clear manner.
Interfacing with other plant functions and functions globally.
Supporting quality/manufacturing projects utilizing Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.
Maintaining good working knowledge of plant systems, processes, procedures, documentation, and products.
Evaluating change to systems and ensuring changes are assessed and executed appropriately per Baxter procedures for implementation.
Managing and prioritizing multiple tasks and projects.
Benchmarking new technologies and methodologies for use in the facility.
Knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly.
Learning, understanding and applying rigorous quality standards, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
Notifying the supervisor and taking appropriate action if any safety, quality, mechanical or discrepancy issues occur.
Sustaining a clean and safe work area using 6S principles.

Benefits

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits