Senior Quality Engineer
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Job Location:
Pensacola, FL - 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 ensuring the quality of membrane products and medical devices by facilitating cross-functional execution of the Quality Management System (QMS) setting inspection processes implementing quality control measures and identifying statistical trends. This role ensures compliance with ISO 13485 and ISO 9001 standards addresses customer complaints resolves production quality issues and supports new product introduction projects. Additionally the Senior Quality Engineer drives continuous improvement and collaborates with R&D manufacturing and regulatory teams to maintain product safety and regulatory compliance.
This position reports to the Senior Manager Site Quality and is part of the Quality Engineering group located in Pensacola and will be an on-site role.
What you will do:
- Lead root cause analysis and implement CAPA for nonconformities using the risk management processes.
- Ensure design control process compliance throughout the product lifecycle and deliver training on quality processes.
- Establish monitor and analyze QMS process performance; lead quality improvement projects.
- Review and approve deviations document changes validation activities and change controls.
- Drive process improvements using Lean/Six Sigma methodologies.
Who you are:
- Bachelors degree in Engineering or related Science field.
- 7 years in medical device quality engineering.
- Strong knowledge of ISO 13485 FDA QSR ISO 9001 and risk management tools.
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.
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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
