Director, Quality Assurance

11 hours ago


San Diego, California, United States Sekisui Diagnostics, LLC Full time

About the Role:

As a Director, Quality Assurance at Sekisui Diagnostics, LLC, you will play a critical role in ensuring the quality of our products and services. You will oversee the development, implementation, and maintenance of quality assurance systems and activities, including the generation and review of documents used in good manufacturing practices. You will also monitor audits of production and quality control areas, and may audit raw material vendors and prepare manufacturing documentation for updated filing. Additionally, you will coordinate interdepartmental activities and may lead investigations and resolve potential product quality issues to improve efficiency.

About Us:

Sekisui Diagnostics, LLC is a leader in in vitro diagnostics, helping to improve patient outcomes by innovating and developing highly accurate diagnostics tests, reagents, and systems. We are committed to embracing change and challenging new frontiers to create unique, high-quality products and services that meet the specific needs of our customers.

What We Offer:

We offer a competitive compensation package, including a base salary of $200,000-$230,000, as well as annual incentives and comprehensive benefits. We are an equal opportunity employer, committed to a diverse workforce and a culture of inclusion.

Requirements:

To be successful in this role, you should have 10+ years of experience in the IVD industry, with thorough knowledge of FDA QSR, ISO 13485, and MDSAP. You should also have strong experience in Firmware, Hardware, and Software Engineering, as well as experience supporting the realization of new products through new product development, third-party manufacturers, and/or mergers and acquisitions, including oversight of Design Controls.



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