Job Information
Danaher Corporation Supervisor Quality Assurance – Development Quality Software Support in Washington DC, District Of Columbia
Supervisor Quality Assurance – Development Quality Software Support
Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.
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 Beckman Coulter product portfolio is diverse and includes new concepts for hardware, software, and clinical decision applications. The Supervisor Quality Assurance will supervise a group of 6 Design Assurance Engineers who are engaged early in software product design and development with an objective 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 business growth objectives.
The position is part of the Diagnostics Development Quality team and reports into the Manager, Quality Assurance. Our goal is to provide high quality, reliable, cost competitive, and regulatory compliant products to market. The Development Quality team exists to ensure our new and improved products are developed in a compliant manner and provided to our customers with the utmost quality to advance healthcare for every patient. If you thrive in a face-paced and diverse role and want to work to build a world-class Quality organization—read on!
This role also includes the following opportunity to:
Supervise staff, allocate resources, and provide work direction to effectively and efficiently achieve portfolio, project and functional goals and objectives.
Working alongside the Manager QA, adapt departmental plans and priorities to address resource and operational challenges, working cross functionally with other managers to align site objectives, as needed.
Use judgement to identify, troubleshoot and resolve technical and operational problems.
Acquire, develop, and retain associates in the group by developing and maintaining a technically excellent, high performing and engaged team.
Recognize and reward achievement, commitment, and excellence in the advancement of organizational, departmental and group strategies.
The essential requirements of the job include:
High school degree with 8+ years of experience, or Bachelor’s degree with 5+ years of experience or Master’s degree with 3+ years of relevant experience.
Minimum 2 years of experience in Quality Assurance, design assurance or demonstrated skills in the new product development process.
Experience in a regulated industry specifically knowledge of IVD and/or Medical Device industry
Experience with Quality System Regulation 21 CFR 820, Quality Management System ISO 13485:2016, and Risk Management ISO 14971:2019
This experience is a plus:
Bachelor’s or Master’s degree in Software, Engineering or related technical field
1+ years of supervisory or management experience
Product Software design assurance in accordance with Software as a Medical Device (SaMD) IEC 62304:2016, 62366-1:2015
Artificial Intelligence or Machine Learning
At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .
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. Please contact us at applyassistance@danaher.com to request accommodation.