What are the responsibilities and job description for the Quality Assurance Engineer position at Cytiva?
Accelerate Your Potential
In a fast-paced world where science and technology are advancing at breakneck speed, we're looking for talented individuals to join our team and make a real difference in life sciences, diagnostics, and biotechnology.
Cytiva, one of Danaher's 15 operating companies, is a global leader in the life sciences industry. Our work saves lives, and we're united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where your unique viewpoint matters. By harnessing Danaher's system of continuous improvement, you'll help turn ideas into impact – innovating at the speed of life.
About Cytiva
We're a community of innovators who share a passion for transforming human health. Our customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
The Role
We're seeking a Quality Assurance Engineer (Design & Manufacturing) to provide quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements. As part of our Quality and Regulatory Affairs Team, you'll lead root cause analysis and CAPA initiatives, oversee manufacturing validation (IQ, OQ, PQ), and support effective design transfers and product launches.
Your Key Responsibilities
- Review and approve change control documentation (ECOs) to mitigate risks to product quality.
- Conduct investigations into manufacturing and design-related failures, ensuring appropriate corrective actions.
- Support disposition of non-conforming materials, leading trend analysis and quality event investigations. Perform other quality-related activities as needed, not limited to supporting audits, training initiatives, and cross-functional collaboration with supporting functions on continuous improvement projects.
- Participate in Deviation and Concession Control Boards, ensuring compliance with quality standards.
- Implement process improvement initiatives using Six Sigma, Lean Manufacturing, DBS, and SPC methodologies.
What We Offer
Cytiva offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a healthcare program or paid time off, our programs contribute to life beyond the job.
Requirements
- Bachelor's degree in engineering, Health Sciences, or a related field.
- Minimum 5 years of experience in Quality or Regulatory in a regulated industry (ISO 9001, medical device, or pharmaceutical preferred).
- Experience with root cause analysis, CAPA management, and validation activities (IQ, OQ, PQ).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Minitab, Visio).
- Knowledge of manufacturing processes, material properties, and product assembly within a regulated environment.
It Would Be A Plus If You Also Possess:
- Experience in a regulated environment such as medical devices (ISO 13485), pharmaceuticals (GMP), or biotechnology.
- Proficiency with quality management systems (QMS) and tools like Veeva, SAP, Oracle, Magic.
- Certification in Six Sigma, Lean Manufacturing, or ASQ (CQE, CQA, or equivalent).
