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Senior Design Quality Engineer Senior Design Quality Engineer
Ref No.: 18-07074
Location: Belmont, California
Senior Design Quality Engineer, Sequencing
Primary Job Responsibilities
· Provide design control and software/systems development guidance to Personalized Health Care software development teams and life cycle teams and be the single point representative for Design Quality Assurance activities on PHC software development project teams. May be a core team member on a Life Cycle Team(s).
· Review and approve documentation consistent with design control regulations and guidance’s dealing with systems/software development, verification and validation practices and GPS design control policy and SOPs. Documentation to include but not limited to DHF documents such as customer requirements, product requirements, design and development plans and reports, verification and validation plans and reports, design transfer documents, labeling, risk management plans and reports, project plans and milestone documentation.
· Convey information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality Management policy.
· Author and, or review/approve Quality Plan and Report at milestones DI, DO and LD. Assist management in assessment of whether project has met requirements to pass milestone.
Assist in the development of high level and departmental SOP’s governing or associated with design control activities/compliance.
 
Education
· Bachelor’s or QE degree in Computer Science, Engineering or related scientific discipline (biomedical engineering, mechanical engineering, electrical engineering) or related biological science field, or equivalent combination of education and work-related experience in the area of software/systems development, verification and validation, required.
· Master's degree or QE in Computer Science, Engineering or related scientific discipline (biomedical engineering, mechanical engineering, electrical engineering) or related biological science field, or equivalent combination of education and work-related experience in the area of software/systems development, verification and validation, preferred.
 
Experience
· Minimum: 3 years: Development and or QA experience of software, instrument systems under design controls and intermediate/advanced knowledge of in vitro diagnostic reagents, instruments and software products including nucleic acid based products related to RMS products and SOPs. Proven interactions with all Quality Management and other departments (Development, GCTA, Regulatory Affairs, and Operations). Strong track record of successful participation on cross functional project teams project teams.
· Preferred: 5 years: Development and or QA experience of software, instrument systems under design controls and intermediate/advanced knowledge of in vitro diagnostic reagents, instruments and software products including nucleic acid based products related to RMS products and SOPs. Proven interactions with all Quality Management and other departments (Development, GCTA, Regulatory Affairs, and Operations). Strong track record of successful participation on cross functional project teams project teams.
· Strong working knowledge of QSR/cGMP, Design Controls, Systems/Software Development, Verification and Validation Principles and Practices, ISO 13485, EU IVD Directive, IEC 62304, Agile Development Methodologies.