Quality Assurance Engineer/Scientist

Beckman Coulter Life Sciences' mission is to empower those seeking answers to life's most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you'll help drive our vision of accelerating answers-and our commitment to excellence.

Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

Do you want to work in Development Quality Assurance? Do you enjoy applying understanding of quality systems, design controls, industry standards and lifecycle processes to product hardware, software, and consumables as part of a cross-functional team? Then read on!

We are currently seeking a Quality Assurance Engineer/Scientist who will be responsible for representing quality assurance on design change teams or product improvement projects for Beckman Coulter Life Sciences. Products supported include flow cytometry systems. The primary role of the position is to provide guidance and direction to cross functional design change teams to meet design control requirements in support of post launch design changes.

In this role, you will be responsible for:

• Partnering with teams ensuring product and service conformance to requirements of 21 CFR 820, ISO 9001, 13485 and/or 27001/SOC2 with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production and Service.

• Assuring compliant process conformance and complete product documentation, inclusive of Design History, Product, Process Service documentation, supporting successful and compliant product realization within the Beckman Coulter quality system.

• Represent all QA functions involved with the project within the change team structure. Support and engage with extended QA team on a regular basis to ensure on time delivery of activities.

• Awareness of industry standards and regulations and how they relate to internal policies and procedures.

• Reviewing and approving documentation related to the projects supported.

The required qualifications for the job include:

• Bachelor's or Master's degree in engineering, science, or related field.

• BS +2 or MS +0 or more years of experience in product support, manufacturing and/or quality in a medical device, pharmaceutical, or regulated field (e.g. FDA, DoD, aerospace, automotive).

• Experience in application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of products and design changes.

• Applied knowledge of problem-solving techniques.

It would be a plus if you also possess previous experience in:

• Application of product software lifecycle and privacy and security requirements and/or Certified Software Quality Engineer (SQA)
• Risk Management (per ISO 14971)
• Lead Auditor Certification

At Beckman Coulter Life Sciences 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 Life Sciences can provide.

The salary range for this role is $75,000 - 90,000. 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.

We may ultimately pay more or less than the posted range. This range may be modified in the future.

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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

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.

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.