Senior Engineer for Regulatory Compliance
3 weeks ago
About Meet
Meet is a leading developer of innovative medical devices. We are seeking a talented Senior Quality Engineer to join our team.
Job Overview
As a Senior Quality Engineer at Meet, you will be responsible for ensuring the quality and compliance of our products. You will work closely with cross-functional teams to develop and implement quality assurance processes that meet regulatory requirements.
Key Responsibilities
- Develop and maintain risk management documentation, including plans, hazard analyses, FMEAs, and software hazard analyses.
- Drive design assurance and development activities, such as engineering studies, feasibility testing, and drawing reviews, for new product development initiatives.
- Create quality assurance specifications, test methods, inspection procedures, sampling plans, and related protocols.
- Lead development and validation of test methods.
- Support product launch processes, master validation plans, product V&V, process validations, and the transition of design to manufacturing.
Requirements
- Bachelor's degree in Engineering or a related scientific field with 4+ years of experience in Quality Engineering, Quality Manufacturing, or R&D; OR a Master's degree in a similar field with 2+ years of relevant experience.
- Hands-on experience in Design Assurance, encompassing Design Controls, Design Freeze, Design Verification & Validation, and Design Test Method Development.
- Experience in a highly regulated industry.
- Familiarity with Software Development Life Cycle Processes per IEC 62304 is highly preferred.
Benefits
The estimated salary for this position is $130,000 - $160,000 per year, depending on qualifications and experience. In addition, we offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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