Join Beckman Coulter Life Sciences as a Staff Quality Assurance Engineer and play a crucial role in enhancing quality systems and product improvements. Collaborate with cross-functional teams to ensure compliance with industry standards and contribute to life-saving innovations in diagnostics and biotechnology.
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 throughout product lifecycle
Partnering cross functionally to ensure product and service conformance with focus on Design Controls, Document Controls, Risk Management (per ISO 14971)
Assuring compliant process and product documentation in support of product realization and commercialization
Awareness of current industry standards and regulations and how they relate to internal policies and procedures
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