Quality Associate II

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. 

Execute Quality System related duties within the facility including, identification of nonconformance associated with Baxter products and processes, the investigation of root cause, execution of correction/containment and corrective/preventive action, verification of CAPA effectiveness! Report on system progress and metrics and serve as subject matter expert for the Nonconformance and CAPA processes! Compile, prepare and present information to the CAPA Review Board/ Tier board structure.  Train and/or mentor site personnel on the CAPA System process to maintain compliance to regulatory and global requirements. Assist with Audit and Field Action related activities as needed. Assist in review of Global procedures and audit findings for impact to Site processes and procedures. Perform activities within prescribed timelines.

FUNCTIONAL RESPONSIBILITIES:

• Own / Approve various Quality System Records.
• Responsible for conducting nonconformance root cause investigation, containment, correction, Field Action, corrective/preventive action, verification of effectiveness and closure activities.
• Identify, implement, and monitor process improvements to ensure continuous improvement to product and process quality.
• Mentor/coach Investigation Owners in developing investigation plan and results.
• Monitor Quality System related activities to ensure timeliness of completion.
• Verify respective functional activities for Quality System records are complete.
• Compile & present information to facility (Medina Plant) and external (i.e. Medina Design Center) CAPA Review Board. Maintain CRB information per established requirements, as needed.
• Develop and provide training as needed. Assist with Quality System Account Request Management.
• Generate weekly nonconformance reports, as needed.
• Participate in Audit readiness activities. Assist with / participate in Internal Audits, Corporate Audits, External Audits, as needed.
• Complete Global Observation Certification reviews and Quality Alert reviews, as needed.
• Provide support to the Change Control Management process by serving as a Quality Assessor.

QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:

• This role requires extensive personnel interaction, including all functions and all levels of the organization.
• Must have computer proficiency
• Ability to work effectively as part of a cross functional team
• Excellent organizational skills
• Excellent presentation skills
• Attention to detail
• Ability to multi-task and work well under pressure.
• Understand scientific strategies and be able to invent new methods or new avenues of investigation.
• Good interpersonal/communication/influencing/negation skills.
• Good project management skills
• True understanding of FDA Regulations, Application of Good Laboratory Practices, and Good Manufacturing Practices.

EDUCATION/EXPERIENCE REQUIRED:

• Bachelors degree required. MS in science/engineering a plus.
•  2 years’ experience in quality with a medical device/pharmaceutical company or similar regulated industry, preferred.
• 
  •Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred.
• 
  •Strong knowledge of risk management, root cause analysis, corrective and preventive action and document control.
• 
  •Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools.
• 
  •Be able to author procedures in response to corrections or corrective actions.
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  •Have computer proficiency with experience in Microsoft Word, Excel, and Access or other database programs. Trackwise proficiency and experience is a plus.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee:

• Be able to stand, sit and walk throughout the work day

WORK ENVIRONMENT:

• Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture.  Some of those work rules include but are not limited to: 

• Wearing a static protective smock at all times while in the work area
• Working in close proximity to other employees.
• Working in an environment that is temperature and humidity controlled. 

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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 AccommodationsBaxter 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 removed ] - Click here to apply to Quality Associate II 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 our [ Link removed ] - Click here to apply to Quality Associate II.