This listing was posted on The Resumator.
Quality Assurance Engineer
Location:
Austin, TX
Description:
Quality Assurance Engineer About Paradromics We are building a direct data interface with the brain to provide technology solutions to unmet medical challenges. A revolutionary leap beyond today’s research-grade brain computer interfaces (BCI), our Connexus® Direct Data Interface (DDI) collects neural signals at an industry-leading high data-rate and is designed for long-term daily use. Our first clinical application will enable severely motor-impaired people to communicate and independently use a computer, translating their neural signals into synthesized speech, text, and cursor control. We will continue to expand the capabilities of our massively scalable platform to support a pipeline of future applications that could benefit millions. The Role As a Quality Assurance Engineer, you support the implementation and maintenance of our Quality Management System and conduct general QE activities. You are responsible for enhancing the understanding of and compliance with medical device standards and regulations across the company. This position is a hands-on Quality Affairs role that involves equipment and production control activities, as well as direct interfacing with engineering and production teams to optimize and document product design, processes, and controls. The role focuses on efficiency and compliance and demands a proactive approach and clear communication to support the company's growth and success. The ideal candidate is a self-starter with a "can-do" attitude who is enthusiastic about working collaboratively and engaging in hands-on, detailed, quality work. This role is crucial in supporting the company's continued development and future success. It is based on-site in Austin, Texas and involves less than 5% travel. Responsibilities Support the maintenance and continuous improvement of the Paradromics’ Quality Management System Effectively communicate Quality Assurance requirements and needs to cross-functional teams Ensure effective use of Design Controls, Verification & Validation (Design & Process), Purchasing Controls, and Document Controls Support the generation and maintenance of risk management files supporting product development, including Risk Management Plans/Reports, Hazard Analyses, FMEAs and other related documents Investigate and resolve quality events such as Nonconformances, CAPAs, Complaints, and Audit findings Support production by collaborating to implement processes and improvements Maintain equipment calibration and qualification records Participate in the development, delivery, and administration of quality training programs Perform Document Controls activities including document review and assessment Maintain metrics for Management Reviews and KPIs to continually monitor the Quality System Required Education Bachelor’s degree in an Engineering, Science, or technical field Required Qualifications 1+ years Quality Assurance experience in medical devices Working knowledge of medical device quality standards and regulations, including FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 Experience supporting external audits (e.g., FDA, EU Notified Bodies, etc.) Experience supporting production activities, including oversight of process validations (IQ/OQ/PQ) Experience conducting impact assessments and change control activities Experience creating work instructions, forms and procedural directions Excellent attention to detail Able to develop creative solutions to complex problems that meet regulations and business needs Able to work effectively in a team environment with a diverse group of people Good written and oral communication skills Preferred Qualifications Certification(s) in a Quality-related discipline (e.g., CQE, 6 Sigma, Lean, etc.) Knowledge of and practical application of IEC 62304 and IEC 62366 requirements Experience with eQMS and ERP software Experience developing active electronic devices (e.g. neuromodulation) Experience in microfabrication/electronics device manufacturing Experience working for a startup medical device company Able to read/interpret engineering drawings featuring GD&T Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. Powered by JazzHR
Company:
Paradromics
Posted:
April 29 on The Resumator
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More About this Listing: Quality Assurance Engineer
Quality Assurance Engineer is a Quality Assurance QA Engineer Job at Paradromics located in Austin TX. Find other listings like Quality Assurance Engineer by searching Oodle for Quality Assurance QA Engineer Jobs.
Quality Assurance Engineer is a Quality Assurance QA Engineer Job at Paradromics located in Austin TX. Find other listings like Quality Assurance Engineer by searching Oodle for Quality Assurance QA Engineer Jobs.