Quality Associate II

Baxter International Inc.; Cleveland (MS); Sur place; USD 88 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage from day 1

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Résumé du poste

Baxter International Inc. in Cleveland is seeking a Quality Systems professional to implement and sustain cGMP-aligned quality systems and procedures in the Devices department. You will guide cross-functional teams, train technicians, and champion continuous improvement across the plant.

The role requires a Bachelor’s degree in a relevant field, knowledge of quality systems, and FDA manufacturing experience; Six Sigma Green Belt and Lean Manufacturing are preferred. Travel may be needed.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry or Engineering.
• Good knowledge of quality systems and procedures.
• FDA manufacturing experience required.
• Six Sigma Green Belt preferred; Lean manufacturing experience preferred.

Responsabilités

• Implement and maintain quality systems and procedures in Devices.
• Interview, hire and train employees; plan and direct work; appraise performance.
• Drive continuous improvement and support equipment upgrades.
• Lead cross-functional teamwork and train technicians.
• Support process validation, capability, and control studies.
• Investigate customer complaints and perform nonconformance actions.
• Track key quality metrics and ensure product conformance.
• Communicate shift activities clearly and interface with global functions.
• Apply Lean tools and 6S; ensure compliance with cGMP and SOPs.
• Maintain plant knowledge of systems and changes per Baxter procedures.

Connaissances

Teamwork

Communication

Independence

Travel

Physical stamina

Overhead reach

Bend and stoop

Visual acuity

Formation

Bachelor's degree (Science/Engineering)

FDA manufacturing

Six Sigma Green Belt

Lean Manufacturing

Description du poste

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.

Job Responsibilities

• Responsibilities will include implementation of the quality systems, processes and procedures in the Devices departments.
• This role is responsible for 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, supporting equipment/system upgrades and new equipment/systems.
• Cross-functional teamwork will be involved in this role as well.
• Responsible for 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
• Responsible for supporting process validation, process capability, and process control studies for assigned areas.
• Responsible for performing customer complaint investigation activities (defect/failure analysis) on product as required.
• Responsible for conducting nonconformance investigations and implementing corrective actions for product/process defects or failures.
• Responsible for trending key quality performance metrics for the Devices departments.
• Capable of making independent decisions regarding product conformance and handle issues as they arise.
• Communicate activities and occurrences from the shift to appropriate persons in an organized and clear manner.
• Must interface with other plant functions and functions globally.
• Must support quality/manufacturing projects utilizing Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.
• Maintain good working knowledge of plant systems, processes, procedures, documentation, and products.
• Evaluates change to systems and ensures changes are assessed and executed appropriately per Baxter procedures for implementation.
• Manage and prioritize multiple tasks and projects.
• Benchmark new technologies and methodologies for use in the facility.
• Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly.
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
• Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur.
• Sustain a clean and safe work area using 6S principles.

Knowledge, Skills and Abilities

• 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.

Required Education and Experience

• Bachelor’s degree in Microbiology, Biology, Chemistry or Engineering required
• Good knowledge of quality systems and procedures
• FDA manufacturing required.
• Six Sigma Green Belt Certification or industry standard equivalent is preferred.
• Lean Manufacturing skills and experience are preferred.

Other Duties as Assigned

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.

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 $88,000 - $110,000 annually. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. 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.

Applicants must be authorized to work for any employer in the U.S. We cannot sponsor or transfer sponsorship of an employment visa.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

• medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

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.

Know Your Rights: Workplace Discrimination is Illegal

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 the Recruitment Fraud Notice.