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Über
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact
innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision makingwe are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. The QA Validation Engineer is responsible for assisting in the sustainment of a robust Master Validation Plan and support of the MVP strategies. This position reports to the Quality Assurance Manager responsible for Validation and is part of the Quality Assurance
Validation department located in Chaska, MN and will be an on-site role. In this role, you will have the opportunity to: Train and mentor individuals and validation teams (both formal classroom and informal) to ensure efficiency and compliance with validation regulations and corporate procedures. Evaluate specifications for requirements and ensure they meet validation standards. Generate test cases and procedures from specifications with minimal guidance. Execute test procedures with minimal guidance and document results accurately. Apply Danaher Business System tools to make continuous improvements across the business. The essential requirements of the job include: Bachelor's degree in a relevant field with 2+ years of experience, OR Master's degree in a relevant field with 0-2 years of experience Experience in software, test method, equipment, process, and/or design testing methodologies. Knowledge of FDA regulations, ISO standards, and GxP guidelines. Experience with Computer System Validation (CSV) and process validation It would be a plus if you also possess previous experience in: Experience in IVD Medical device or Pharmaceutical Manufacturing ASQ Certification The salary range for this role is $75-95K. This is the range that we, in good faith, believe is the range of possible compensation for this role at the time of this posting. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Sprachkenntnisse
- English
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