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Engineering (Non IT) and Research - Quality Engineer III

3 months ago

Fremont, United States Cogent infotech Full time
Job Description: Design, implement and review test plans and protocols to ensure that medical device/equipment products meet all quality standards. Oversee product quality throughout the entire product design realization process. Work closely with research and development to support new product development and improve product design. Investigate non-conformances and suggest changes as necessary. Work under general supervision with latitude for independent judgment. Required to consult with internal stakeholders on certain projects as required. Responsibilities: Lead, Support and monitor new product development project needs in design controls for adherence to the internal quality management system and all ISO, FDA, IVDR and QSR regulations. Drive and ensure proper design controls are appropriate during design reviews. Manage input to operations regarding quality issues such as process improvements and risk (DFMEA & PFMEA) updates. Manages the pre- & post-production Design Assurance/Quality Engineering activities as they relate to product lifecycle development Review and approval of validation protocols and reports. Work with Supplier Quality and Supply Chain groups to ensure product suppliers are effectively developed. Verify configuration management and Risk Analysis records are properly addressed, accurate, and maintained. Review test protocols and final reports for completeness and accuracy. Ensure design changes are processed in accordance with current change-control requirements. Manage and complete assigned tasks on schedule, and identify and propose resolution for issues that may affect the timeline for remediation activities. Provide quality engineering support for investigations as required. Coordinate resolution of potential quality assurance deficiencies discovered during the product realization process. Lead and support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required. Required Qualifications: Bachelor's degree with a minimum of 7 years of experience in medical device quality assurance. Strong interpersonal skills with the aptitude to be a team player; setting a professional tone and establishing a cooperative partnership within the department and other areas of the company Demonstrated and impactful experience in product and process validation, software validation (device & quality system support), test method validation, Statistics, Risk Management Tools and Process Control & Monitoring (SPC). Ability to interpret trends and data, translating the information into actions, outcomes and improvements Excellent documentation skills, with a solid process orientation and effective attention to detail Strong verbal and written communication skills Self-starter and independent critical thinker, with the aptitude to work autonomously Proficiency in all MS Office products Quality engineering certification (ASQ CQE or CQA) desired Knowledge of lean six sigma manufacturing processes Additional professional training in lean processes such as green belt training a plus Exact Schedule - M-F 8am-5pm
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