As a Staff Quality Assurance Engineer at Beckman Coulter Life Sciences, you will play a pivotal role in applying quality systems and design control processes across product development. Your expertise will support the development of life-saving therapies by ensuring compliance and quality throughout the lifecycle of instrumentation, software, and consumables.
Key Responsibilities
Representing quality assurance on development teams and quality systems
Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes
Partnering cross functionally to ensure product and service conformance
Assuring compliant process and product documentation
Awareness of current industry standards and regulations
Required Qualifications
Degree in engineering or other science or related field or equivalent experience
BS+7 or MS+4 years’ experience in product development, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries
Preferred Qualifications
Ability to identify, develop and execute quality system, product and process improvements
Driving change cross functionally across multi-site operations