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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

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Summary:

This section focuses on the main purpose of the job in one to four sentences.

Provide engineering support in the development and maintenance of the company’s quality system. This position is responsible for ensuring site compliance with the Quality System procedures and requirements and lead the development of quality plans, NCRs, CAPAs, supplier issue management and support manufacturing. Additionally, this individual is responsible for supporting incoming inspection through training, component throughput, material review and prioritizing inspection activities.    

Essential Duties and Responsibilities:

• This section contains a list of five to eight primary responsibilities of this role that account for the majority of the work. The incumbent will perform other duties assigned.
• Responsible for reviewing pertinent documents, records and reports against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Identify areas of non-conformance and inform management as needed to be disposed (unilaterally accepted or rejected) by others. NCRs at this level are minor.
• Owns NCRs and CAPAs, performs investigative actions, applying well-established techniques and procedures and identifies and implements corrections, corrective and preventive actions as well as effectivness.
• Revise or review standard procedures.
• Coordinate inspection related activities in support of manufacturing including performing inspections or tests of purchased parts. Coordinate the reporting, analysis, and resolution of material non-conformance incidences including active participation in Material Review Board and other meetings as needed. Support and coordinate supplier related quality activities to ensure continued improvement.
• Plan, initiate, conduct and manage projects, including quality projects, in support of company’s strategic plan independently or in cross-functional teams. Complete projects in a manner consistent with corporate objectives.
• Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Partners with site functions and corporate entities to ensure successful implementation and compliance to procedures / regulations.
• Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Strong interpersonal skills and great attention to detail are necessary.
• Must be a strong team player with good problem solving, and good verbal and written communication skills.
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

Education and/or Experience:

Include the education and experience that is necessary to perform the job satisfactorily.

BS in business/science or equivalent degree. 3-5 years experience in Quality with a medical device or other similarly regulated industry.

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.
                                                                                                                                                               
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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.