Quality Assurance Engineer II

Danaher

  • Bothell, WA
  • $75,000-100,000 per year
  • Permanent
  • Full-time
  • 15 days ago
Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Cepheid, one of 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.Learn about the which makes everything possible.The Quality Assurance Engineer II is responsible for ensuring product quality of enzyme, chemical and oligonucleotide reagent products, supporting facilities and equipment qualification, and strengthening compliance to FDA’s Quality System Regulation and ISO13485 Standard. This position will make significant impact to the Bothell site by supporting facility growth and reagent products development and sustainment.This position reports to a Senior Quality Assurance Engineer and is part of the Quality Department located in Cepheid Bothell, Washington facility and will be an on-site roleIn this role, you will have the opportunity to:
  • Qualify equipment, utilities and facilities, validate production processes and test methods. This includes developing, advising, writing, or reviewing protocols, providing guidance during protocol execution, deviation investigations, test result analysis and final reports.
  • Represent Quality by collaborating with product or facility project teams, driving risk management, and focusing on controls, process transfer, validation, data analysis, monitoring, and continuous improvement.
  • Support Quality System processes to ensure compliance to the Cepheid Quality Management System by identifying compliance gaps, writing or revising procedures, and implementing processes to improve efficiency while ensuring compliance.
  • Provide support to back room, front room, or act as a subject matter expert during internal or external audits. Support manufacturing and design control teams in audit preparedness.
  • Manage or contribute to change control processes to ensure sustainment and compliance across manufacturing disciplines.
  • Advise New Product Implementation core teams to ensure adherence to design control deliverables from technical feasibility through process validation.
The essential requirements of the job include:
  • Bachelor’s degree in an Engineering discipline, or a chemistry / life science discipline
  • 2+ years of relevant work experience in a quality, validation, or engineering based role.
  • Experience in qualification and validation of equipment, facilities and processes.
  • Experience in risk analysis.
  • Ability to work in laboratory environments.
It would be a plus if you also possess previous experience in:
  • Experience in a FDA regulated industry or ISO certified organization, for example: FDA’s 21 CFR 820 regulation or ISO 13485:2016 standard.
  • Experience with chemistry production (especially oligonucleotide chemistry).
  • Bachelor’s degree in Chemical Engineering preferred
Cepheid, a Danaher operating 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 .The annual salary range for this role is $75k – $100k. 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.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.#LI-LCSJoin our winning team today. Together, we’ll 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.For more information, visit .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.The U.S. EEO posters are available .We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or .

Danaher