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The Staff Quality Assurance Engineer will represent quality assurance on development core teams, current business project teams or product improvement projects for Beckman Coulter Life Science.   Products supported include laboratory automation, centrifugation, genomics, flow cytometry, particle counting and particle characterization systems.   Candidates will apply understanding of quality systems, design controls, industry standards and lifecycle processes to product hardware and software including embedded, product and cloud environments. 

Responsibilities:

•    Assures compliant process conformance and complete product documentation, inclusive of Design History, Product, Process Service documentation, supporting successful and compliant standard and custom product realization within the Beckman Coulter quality system.
•    Partners engineering to ensure product and service conformance to requirements of ISO 9001, 13485, 21 CFR 820 and/or 27001/SOC©2 with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls, Product Privacy and Security.  
•    Coaches teams with application of product software lifecycle, verification and validation requirements for FDA device software guidance and IEC62304 standards.  
•    Guides application of GxP non-product software development and validation under industry standards and regulations including GAMP, 21 CFR Part 11. 
•    Aware of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance.
•    Able to identify, develop and execute quality system, product and process improvements including drive change cross functionally across multi-site operations.

BS Degree in electrical, mechanical, computer or other engineering discipline; science or related field; or equivalent experience required.
MS Degree or higher preferred
BS+5 or MS+3 years’ experience in product development, manufacturing and / or quality in medical device, pharmaceutical, or related regulated field (e.g FDA, DoD, Aerospace, Automotive) 
Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired