Quality Associate II

Baxter Healthcare; Illinois; On-site; USD 80,000 - 110,000; Full time

Job summary

Ein etabliertes Unternehmen im Gesundheitswesen sucht einen Qualitätsmanager, der eine Schlüsselrolle bei der Sicherstellung der Produktqualität spielt. In dieser spannenden Position werden Sie für die Vorbereitung und Überprüfung von Kundenlisten verantwortlich sein, um sicherzustellen, dass alle Feldaktionen ordnungsgemäß durchgeführt werden. Ihre Expertise in regulatorischen Standards und Qualitätsmanagement wird entscheidend sein, um die Effizienz und Genauigkeit in einem dynamischen Umfeld zu gewährleisten. Sie werden die Möglichkeit haben, mit verschiedenen Teams zusammenzuarbeiten und Ihre Fähigkeiten zur Problemlösung und zum Projektmanagement zu nutzen, während Sie zur Verbesserung der Patientenergebnisse beitragen. Wenn Sie eine Leidenschaft für Qualität und eine positive Einstellung haben, ist dies die perfekte Gelegenheit für Sie.

Benefits

Medizinische und zahnärztliche Abdeckung

401(k) mit Unternehmensmatching

Mitarbeiteraktienkaufplan

Flexible Ausgabenrechnungen

Bildungshilfen

Bezahlte Zeit off

Elternzeit

Mitarbeiterrabatte

Mitarbeiterhilfeprogramm

Kinderbetreuungsleistungen

Qualifications

• 3-5 Jahre Erfahrung in der Qualitätssicherung in regulierten Branchen.
• Kenntnisse über ISO9001, ISO13485 und FDA-Vorschriften.

Responsibilities

• Vorbereitung und Überprüfung von Kundenlisten für Feldaktionen.
• Zusammenarbeit mit Dritten zur Dokumentation und Nachverfolgung.

Skills

Qualitätsmanagement

Regulatorische Kenntnisse

Projektmanagement

Microsoft Office

Interpersonelle Fähigkeiten

Problemlösungsfähigkeiten

Education

Bachelorabschluss in Wissenschaften oder Ingenieurwesen

Tools

JD Edwards

Job description

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.

Your role at Baxter

Prepares customer lists, mailings, and effectiveness checks for US (and Guam) field actions. This could include pulling data from JD Edwards, requesting a customer list from the US hardware tracking team, or receiving an Adhoc customer list from the manufacturing site. The customer data is reviewed and further cleaned as needed for further processing. This person will also serve as an back-up FA owner, as needed.

What you'll be doing

• Submits field action affected product table criteriam jobs in JDEdwards system & extracts data from for US (and Guam) FA customer lists
• Works with Field Action Owners and manufacturing site Adhoc customer list preparers to Review and
• Clean Ad hoc customer list data (remove duplicates, format data, etc.) for mail merges, FDA package submissions, and Baxter electronic Field Action System (FAS).
• Subject Matter Expert for Field Action customer list preparation, tracking purposes, training and system implementation
• Works directly with third party vendor to complete effectiveness steps/tracking and documents output into FAS.
• Prepares effectiveness check summary document used for FDA closure package
• Provides input, updates and feedback regarding functionality and content quality related to internal and external Customer Data Tracking and Field Action systems
• Works with the Baxter’s copy center/mail room to mail customer communications
• Provides FA data to Legal team regarding home patient documentation, as needed
• Receives third party vendor/internal feedback regarding updates/status changes to customer list data and communicates to appropriate internal teams
• Respond or re-direct requests received from the Field Action Team General Mailbox
• Support creation of FA Stakeholders Contact List for new issue escalations
• Serves as a back-up FA owner, as needed

What you'll bring

• Bachelor’s Degree in Sciences or Engineering

• 3-5 years of experience in Quality with a Medical Device/Pharma company or other similarly regulated industry
• Knowledge and understanding of regulations and standards (e.g. ISO9001, ISO13485, FDA 21CFR Parts 7,11,803,806,810,820, 821).
• Working knowledge of Baxter products, procedures, and internal electronic systems is preferred.
• Proficiency in Microsoft Office (e.g. Excel, Word, OneNotes, and PowerPoint)
• Excellent written/oral communication, problem-solving skills, and attention to detail.
• Self-motivated with the ability to work independently and make decisions.
• Strong project management skills.
• Demonstrated interpersonal skills and ability to lead others in interactions with people at all levels.
• Ability to perform multiple tasks simultaneously and work cross-functionally in a highly matrixed environment.
• General organizational office skills
• Knowledge of Good Documentation Practices and Good Manufacturing Practices.

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 $80,000 - $110,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. 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 are unable to sponsor or take over sponsorship of an employment visa at this time.

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

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 our Recruitment Fraud Notice.

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