Quality Assurance Specialist
3 weeks ago
Meet your next challenge as a Quality Assurance Specialist at Meet, where you will play a pivotal role in ensuring the compliance of our medical devices with regulatory standards. As a Senior Quality Engineer, you will leverage your expertise in quality engineering principles and methodologies to drive excellence in product development, manufacturing, and distribution processes.
Key Responsibilities:
- Deliver engineering expertise in Quality Assurance, Design Controls, Risk Management, and Statistical Techniques.
- Drive design assurance and development activities, such as engineering studies, feasibility testing, and drawing reviews, for new product development initiatives.
- Develop and maintain risk management documentation in line with ISO 14971 and applicable regulations, including plans, hazard analyses, FMEAs, and software hazard analyses.
- 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.
- Provide daily support to production teams, actively engaging in assembly operations and continuously improving systems for compliance and manufacturing excellence.
- Oversee changes to existing products, SOPs, work instructions, test methods, processes, design, labeling, and field issue resolutions, ensuring regulatory requirements are met for submissions and notifications.
- Prepare documentation for regulatory submissions and global product registrations.
- Assist in supplier evaluation, selection, and qualification processes.
Qualifications:
- 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.
- Knowledge of Usability Engineering Processes in line with IEC 62366 is advantageous.
Estimated Salary: $120,000 - $160,000 per year, depending on experience.
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