Baxter QA Inspector in St Paul, Minnesota
*About Baxter * Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Essential Duties and Responsibilities: * Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. * Approves incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials. * Maintains a working knowledge of statistically based Sampling Plans and their applications. * Documents inspection results by completing forms, reports and logs. * Initiate Nonconforming Material Reports for incoming materials that does not meet Baxter requirements, e.g. summarizing failures, re-work and scrap; inputting data into quality database. * Keeps measurement equipment operating by following operating instructions and ensuring the accuracy of measuring and testing equipment per calibration and preventive maintenance schedules * Support the corrective and preventive action program by assisting with investigations as requested. * Perform First Article Inspection and component qualification testing as requested. * Responsible for gathering, analyzing, summarizing, and distributing inspection relevant data. * Monitor materials through the implementation Statistical Process Control (SPC). Responsible for generating and interpreting SPC control charts. * Promote continuous improvement through participation (i.e. team leader / facilitator or major contributor) in process improvement programs. * Must be able to effectively communicate across all departments and levels of management. * Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations. * Updates job knowledge by participating in educational opportunities; reading technical publications. * Accomplishes quality and organization mission by completing related results as needed.
- Basic knowledge of cGMP documentation and FDA regulation required.
- Knowledge of Good Documentation Practices (GDP) required.
- Demonstrated ability to follow procedures and understand technical documentation including material specifications and component drawings required.
- Demonstrated attention to details and accuracy required.
- Ability to analyze information, properly document and report results.
- Must have good communication skills.
- General knowledge of quarantine and warehouse operation helpful.
- Able to work in controlled environment areas as needed (gowning required).
- May be required to work flexible hours and overtime on short notice.
- Bachelor’s degree with 0-2 years related experience or Associates with 1-3 years related experience or High School diploma with 2-4 years related experience.
- Experience in Medical Device industry helpful.
- Must be familiar with cGMP and FDA requirements.
A Career That Matters Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
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 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 toAmericas_TTA@baxter.comand let us know the nature of your request along with your contact information.
Organization: *Global Quality - US/Canada Operations
Title: QA Inspector
Location: Minnesota-St Paul
Requisition ID: 18000GFJ