Senior Quality Engineer
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Job Location:
Duncan, SC - USA
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 Danaher Business System which makes everything possible.
The Senior Quality Engineer is responsible for providing quality assurance services to ensure the integrity of products received and shipped out services provided to clients support business and customer needs and comply with government regulations industry and Cytiva standards. This position reports to the Sr Manager Site Quality and is part of the quality team located in Duncan SC and will be an on-site role.
What you will do:
Maintain and implement Standard Operating procedures process flow charts Process Control Plans Process FMEA change controls and validations.
Lead or support site level projects and initiatives ensuring Quality Assurance priorities are fully integrated in operational strategies and regulatory compliance is maintained.
Partner with cross-functional stakeholders to support expansion risk mitigation and productivity while ensuring product quality.
Manage Non-conformance CAPA and Complaint processes; perform root cause analysis and implement robust corrective actions. Verify effectiveness to prevent recurrence and ensure timely closure.
Provide manufacturing quality trend analysis and recommend improvements. Support Kaizen and Shin Kaizen events using Lean manufacturing principles and Danaher Business System tools to drive continuous improvements.
Who you are:
Bachelors degree in engineering (e.g. Biomedical Chemical Pharma Industrial Mechanical Systems Quality Reliability) or equivalent work experience.
Experienced in managing quality workflows including qualification auditing change management CAPA resolution deviations and QMS development.
Strong interpersonal and communication skills to implement and execute strategies that ensure compliance with regulatory and industry standards.
It would be a plus if you also possess previous experience in:
Strong problem solving and root-cause analysis skills with the ability to influence others to drive change (cross-functionally and globally).
Experience with electronic QMS platforms (VEEVA Magic) and SAP Inventory Management preferred.
Cytiva a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
Join our winning team today. Together well accelerate the real-life impact of tomorrows 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 here.
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- or .
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more
