Staff Quality Assurance Scientist

19 Nov 2024

Vacancy expired!

Wondering what’s within Beckman Coulter? 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 Chemistry & Immunoassay product portfolio is diverse and includes new concepts for hardware, software, and clinical decision applications. This role is integral to the support of Development/Design Assurance QA functional core team in the design and development of existing and new products. This individual is involved from initiation through market release striving to provide high quality, reliable, and regulatory compliant products to market. You’ll drive to achieve products that comply with Design controls requirements by using the Danaher Business System tools.The Staff Quality Assurance Scientist position is open in Chaska, MN with an option to be hybrid or possibly remote, and reports to the Manager, Quality Assurance. If you thrive in a fast-paced role and want to work to build a world-class Development Quality Assurance organization—read on!In this role, you will have the opportunity to: Fulfill the Development QA / Design Assurance role on Reagent Product Development Core or Design Change Teams as the design progresses through the development process.

Collaborate constructively with other functional group Core Team or Change Team members in defining performance requirements, conducting risk analysis, and verification test plan execution.

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 14971

Ensure 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.

The essential requirements of the job include:Bachelor’s degree with 9+ years of experience or Master’s degree with 7+ years or Doctoral with 4 years of relevant progressive professional experience

3+ years of experience in QA, design assurance or proven skills in the new product development process.

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:Degree in Biochemistry, Chemistry, Biology, or similar scientific field

Reagent product development and manufacturing processes in Diagnostics industry

Experience in a regulated industry specifically knowledge of IVD and Medical Device industry

#LI-MR1Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be fully vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.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. If you’ve ever wondered what’s within you, there’s no better time to find out.

Full-time
  • ID: #23023113
  • State: Georgia Atlanta 30301 Atlanta USA
  • City: Atlanta
  • Salary: USD TBD TBD
  • Showed: 2021-11-19
  • Deadline: 2022-01-18
  • Category: Et cetera