Quality Assurance Engineer

Danaher

  • Muskegon, MI
  • Permanent
  • Full-time
  • 13 hours ago
Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Cytiva, 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.Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.Learn about the which makes everything possible.The Quality Assurance Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site Validation Master Plan.This position reports to the Quality Assurance Manager and is part of the Quality Assurance Department located in Muskegon, MI and will be an on-site role.What you will do:
  • Review and approve user requirement documentation (URS), Failure Mode Effect Analysis (FMEA) and equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation (CSV) protocols and/or Plans and Reports.
  • Assist and approve deviation investigations, corrective and preventative actions (CAPAs), process improvements related to equipment qualification and validation activities.
  • Be the subject matter expert for Change Control on launched products, managing the local Change Management Board.
  • Improve and develop QMS work instructions and cross train as a backup for other QA members.
  • Participate in quality walks and internal audits to ensure compliance with industry standards.
Who you are:
  • Bachelor's degree from an accredited University or College, preferably in a Science or Engineering discipline.
  • Multiple years working experience in Quality Assurance/Quality Engineering.
  • Experience in equipment qualifications, process validations, cleaning validations and computer software validations.
  • Previous experience in root cause, corrective action, preventative action and process improvement.
  • Understanding of ISO 9001, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) requirements.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
  • Ability to travel up to 10% a year.
  • Must have a valid driver’s license with an acceptable driving record.
  • Ability to lift, move or carry equipment up to 10lb frequently, and up to 25lbs infrequently.
It would be a plus if you also possess previous experience in:
  • Life Science, Pharmaceutical, Medical Device or Biopharma manufacturing environments.
  • Analytical and problem-solving skills.
  • Strong communication skills (written and oral) with associates at all levels of the organization.
Cytiva, 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 .At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.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.Join 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 .

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