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Staff Quality Assurance Engineer - West Sacramento, CA, United States - Beckman Coulter Diagnostics
Description
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward.
Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates.Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher.Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Staff Quality Assurance role for Beckman Coulter Diagnostics supports cross-functional core team members in the software product design and development lifecycle of the Microbiology Business Unit in West Sacramento, California.
You will be part of the US Diagnostics Development Quality (Design Assurance) team and report to the Manager of Quality Assurance responsible for Diagnostic Software Development Quality.
Our goal is to provide high-quality, reliable, and regulatory-compliant products to support worldwide market release in meeting the needs of our clinical customers, our patients, and Beckman's business growth objectives.
If you thrive in a fast-paced and diverse role and want to work to build a world-class Quality organization—read onFulfill the Development QA / Design Assurance role on Software Product Development Core and/or Design Change Teams as the design progresses through the development lifecycle.
Collaborate constructively with other functional group team members to define performance requirements, conduct risk analysis, and establish right-size verification test plans.
Facilitate risk assessments for new designs and design changes at various project development phases. Ensure that risk management activities are performed in accordance with company procedure and ISO 14971Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project-specific plans.
Assure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.
Drive continuous improvement of new product development procedures, methods, tools, techniques, training, etc., to support project-specific efficiencies.BS in Software Engineering or related technical field with 9+ years of experience, a Master's degree in a field with 7+ years of relevant experience, or a Doctoral degree with 4+ years of experience
~1-2 years of experience within product design and/or manufacturing environment supporting software/hardware development projects.
~ Proven knowledge of design control processes, including design change, risk management, design requirements, design V&V, and design transfer
It would be a plus if you also possess previous experience in:
Artificial Intelligence or Machine Learning
Quality Assurance
Agile Development
Experience in a regulated industry, specifically knowledge of IVD and the Medical Device industry
We recognize the benefits of flexible working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.
This position is eligible for an on-site work arrangement which is defined as being on-site a minimum of 3 days each week.
The other 2 days can be on-site or remotely from your home. Additional information about this work arrangement will be provided by your interview team. The salary range OR the hourly range for this role is $110k-$125. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.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.
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.
We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
