Join Beckman Coulter Life Sciences as a Staff Quality Assurance Engineer, where you will play a key role in quality assurance across product development teams. Your expertise in quality systems will help ensure compliance and drive innovation for life-saving products in a collaborative environment.
Key Responsibilities
Representing quality assurance on development teams, quality systems, and product improvement projects
Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes
Partnering cross-functionally to ensure product and service conformance with focus on Design Controls, Document Controls, Risk Management
Assuring compliant process and product documentation in support of product realization and commercialization
Influencing interpretation of internal policies and procedures to ensure quality and compliance
Required Qualifications
Degree in engineering or other science or related field
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
Certified Software or Quality Engineer (SQA) preferred
Auditor Certification desired
Experience with product software development lifecycle management