Senior Quality Assurance Engineer
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Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
At Beckman Coulter Diagnostics one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 laboratorys 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. Learn about the Danaher Business System which makes everything possible.
The Senior Quality Assurance Engineer is part of the Miami Process Validation Group specializing in all types of validation deliverables. Located in Miami/Hialeah the role involves travel between sites contributing to an environment of impeccable compliance that provides a competitive advantage to our partners.
The Quality Assurance engineer is a key member of the Miami PV team located in Miami reporting to the Senior Manager Process Validation. You will collaborate with senior QA staff taking responsibility for Process Validation & QA Instrument Shared Services within instrument manufacturing. If you thrive in a constantly changing multitasking role and are eager to build a world-class Process Validation / Instrument QA organization we encourage you to apply.
In this role you will have the opportunity to:
- Write and conduct IOQ and spreadsheet validations.
- Complete PQ TMV AQ and NPSV validations.
- Manage process and product non-conformances in line with company procedures.
- Develop maintain monitor and audit quality management system and protocols including systems automation processes and procedures that ensure compliance with regulations and standards.
The essential requirements of the job include:
- Bachelors degree in engineering (mechanical electrical chemical bioengineering or a related area) and 5 years of experience in the medical device industry.
- Familiarity with CFR 21 Part 820 and ISO13485.
- Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems.
It would be a plus if you also possess previous experience in:
- Knowledge of PQ TMV AQ NPSV validations.
- Exposure to Gamp5 or similar regulations.
- ASQ Certified Quality Engineer (CQE).
Beckman Coulter Diagnostics a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job.
Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.
For more information visit .
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.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .
Required Experience:
Senior IC
Key Skills
- Continuous Integration
- APIs
- Jenkins
- Test Cases
- Performance Testing
- Quality Assurance
- Agile
- Jira
- Software Testing
- Java
- Test Automation
- Selenium
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more
