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Principal Scientist

PRINCIPAL SCIENTIST - DQA SW/System Temp
Provide design control and software/systems development guidance to new and, or revised product development teams and life cycle teams and be the single point representative for Design Quality Assurance activities focus on regulation compliance for the Project Teams dealing with system and software products.
Review and approve documentation consistent with design control regulations and guidance's dealing with systems/software development, verification and validation practices and RMS policy and SOPs. Documentation to include but not limited to DHF documents such as customer requirements, product requirements, system development plans and reports, verification and validation plans and reports, anomaly analysis and resolutions, design transfer documents, configuration management, 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 milestone phases. 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.

Minimum Required:
Bachelor's Degree in Computer Science, Engineering, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
Preferred:
Master's Degree in Computer Science, Engineering, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
Minimum Required Job Related
Experience:
5-years Development and or compliance 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 product and SOP's. Proven interactions with all Quality Management and other departments (Development, GCTA, Regulatory Affairs, and Operations). Strong track record and successful participation on cross-functional technical/ project teams.
Preferred Job Related
Experience:
8 - 10 years Development and or compliance 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 products and SOP's. Proven interactions with all Quality Management and other departments (Development, Regulatory Affairs, and Operations). Strong track record of successful participation on cross-functional technical/ project teams.
Other Qualifications:
Strong working knowledge of QSR/cGMP, 21 CFR 820, Systems/Software Development, Verification and Validation Principles and Practices/FDA GPSV, ISO (e.g 13485,14971), EU IVD Directive, Strong conflict resolution skills. Managing multiple projects in parallel with minimal supervision
LOCALS ONLY / MUST BE AUTHORIZED TO WORK IN U.S.


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