Description
Principal / Sr. Scientist will provide design control guidance to new and, or revised product development teams and life cycle teams and be the single point representative for all Quality Management activities for Life Cycle and Project Teams. Review and approve documentation consistent with design a control regulations and guidance's and policy and SOP's. Documentation to include but not limited to DHF documents such as customer requirements, product requirements, design and development plans and reports, non-clinical protocols and reports, design transfer documents, labeling, clinical and reports, process validation plans and reports, risk management plans and reports, project plans and milestone documentation.Minimum Required: Bachelor's Degree in Chemistry, 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 Chemistry, 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 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 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, GCTA, Regulatory Affairs, and Operations). Strong track record of successful participation on cross-functional technical/ project teams.
Other Qualifications: Strong working knowledge of QSR/cGMP, Design Controls, Systems/Software Development, Verification and Validation Principles and Practices, ISO, EU IVD Directive