Senior Quality Assurance Specialist Medical Devices
hace 3 semanas
Overview:
Viant Medical is a leading company in the medical devices industry, and we are currently seeking a highly skilled Senior Quality Assurance Specialist to join our team. This role will be responsible for ensuring that our products meet the highest standards of quality and safety.
Job Summary:
We are offering a competitive salary of $85,000 - $110,000 per year, depending on experience, for this exciting opportunity. As a Senior Quality Assurance Specialist, you will be responsible for providing quality engineering support to the development and production of Class II Medical Devices. You will represent quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, and support new product development activities. You will also maintain and manage quality compliance and supplier quality management.
Main Responsibilities:
- Prepare and update quality documents: You will prepare and update quality documents and any applicable documentation required to sustain the manufacturing process, system or NPI projects, including but not limited to documentation linked to the Device Master Records and Device History Records.
- Execute reviewing / approval of documentation: You will execute reviewing and approval of any documentation created or updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
- Support analysis and implementation of new methodologies: You will support in analysis, review and implementation of new methodologies, processes, tools that contribute to the improvement on the manufacturing process, quality systems or supplier improvements.
- Checks, provides support and executes initiation / investigation: You will check, provide support and execute initiation / investigation for NCs, Complaints, Calibration, SCARs and Environmental Monitoring.
- Provide follow up to actions generated from corrective and preventive plans: You will provide follow-up to actions generated from corrective and preventive plans.
- Perform other duties, tasks, or projects: You will perform other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
Requirements:
To be successful in this role, you will need to have a Bachelor's degree in engineering or science (such as Pharmacy, Microbiology, Physics and Chemistry). You must also have a minimum of 1-year work experience in a manufacturing environment. Bilingual English/Spanish is preferred, with intermediate English level, reading and listening comprehension, writing and oral expression. You should also have basic knowledge of applicable regulations for the medical device industry (FDA, ISO, other.) and basic knowledge in root cause analysis tools. Knowledge of Six Sigma Methodology and Lean Manufacturing is a plus, as well as knowledge of Minitab statistical software.
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