Danaher Corporation Senior Quality Systems Specialist - Bothell in Bothell, Washington
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Senior Quality Systems Engineer is responsible for strengthening compliance to FDA’s Quality System Regulation and ISO 13485, improving the quality processes, and ensuring product quality of enzyme, chemical and oligonucleotide reagent products.
This position is part of the Quality Department and will be located in Bothell Washington.
In this role, you will have the opportunity to:
Provide support for validation of production processes and test methods which includes providing input and approval to process design planning, risk management, writing or approving protocols and final reports, deviation investigation and resolution.
Represent QA by collaborating on new product development and production process improvement teams focusing on design controls, change controls, risk management, process transfer, validation, and monitoring.
Conduct or support production related investigations driving to root cause determination and corrections.
Prepare complex data analysis and written reports,
Write or approve change controls, deviation reports, CAPAs and other documents and records for accuracy, completeness, and compliance.
Identify compliance gaps, write or revise procedures, and implement processes to improve efficiency while ensuring compliance.
Perform internal audits and provide training
Minimum Requirements – Education and Experience
Bachelor’s degree in life science discipline and at least 5 years of relevant work experience
Experience applying knowledge of CFR 21 Part 820 (QSR), ISO 13485.
Experience in the application of production and process controls including validation, process control plans and statistical process control.
Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
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 tools and the stability of a tested organization.
Danaher 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.
If you’ve ever wondered what’s within you, there’s no better time to find out.
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 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 202.419.7762 or firstname.lastname@example.org to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid