Senior Manufacturing Quality Engineer
hace 1 mes
Overview
Viant Medical is seeking a Senior Manufacturing Quality Engineer to support the development and production of Class I, II and III medical devices.
Salary
The estimated salary for this position is between $85,000 and $110,000 per year, depending on location and experience.
Job Description
This role will provide quality engineering support to the development and production process. Key responsibilities include:
- Developing new processes inspections by interfacing with product design and development, quality assurance, production, manufacturing, and external vendors/customers
- Preparing quality metrics for Management Review meetings
- Reviewing drawings, analyzing tooling, and recommending improvements to increase productivity, quality, and safety
- Coordinating qualification and validation activities for new products, processes, changes, and transfers as per FDA regulations
- Investigating audit non-conformances, complaints, and Corrective and Preventive Actions (CAPA)
Required Skills and Qualifications
To be successful in this role, you should have:
- A bachelor's degree in Engineering or Science (such as Pharmacy, Microbiology, Physics, and Chemistry)
- At least 2 years of work experience in a manufacturing environment
- Project management experience
- Knowledge of applicable regulations for the medical device industry (FDA, ISO, etc.)
- Knowledge of test method validation, root cause analysis tools, Minitab statistical software, Six Sigma Methodology, and Lean Manufacturing
Benefits
Viant Medical provides equal employment opportunities to all employees and applicants without regard to race, color, religion, gender, sexual orientation, nationality, age, disability, marital status, amnesty, or veteran status, in accordance with federal, state, and local laws.
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