Director, Quality Assurance

Company: Sekisui Diagnostics GmbH
Location: San Diego
Posted on: November 13, 2024

Job Description:

At SEKISUI Diagnostics, a leader in in vitro diagnostics, we help improve patient outcomes by focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. As a Director, Quality Assurance, you will play a critical role in our mission by creating targeted content that reaches health care providers to showcase how our products can improve the lives of their patients.Who are you? You will oversee the development, implementation, and maintenance of quality assurance systems and activities. Oversee the generation and review of documents used in good manufacturing practices. Monitor audits of production and quality control areas. Audit raw material vendors and prepare manufacturing documentation for updated filing. Coordinate interdepartmental activities. Lead investigations and resolve potential product quality issues to improve efficiency. Select, develop, and evaluate personnel to ensure the efficient operation of the function.To be successful in this role, you should preferably have 10+ years of experience in the IVD (reagent and/or instrumentation) industry. You should have thorough knowledge of FDA QSR, ISO 13485, and MDSAP. Have strong experience in Firmware, Hardware, and Software Engineering. You should also have experience supporting the realization of new products through new product development, third-party manufacturers, and/or mergers and acquisitions, including oversight of Design Controls.About us: At SEKISUI Diagnostics, we help improve patient outcomes by focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. We will continue to embrace change and challenge new frontiers to create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world.Compensation: SEKISUI Diagnostics offers competitive compensation. The anticipated base salary for this position is $185,000-215,000. This role may also qualify for annual incentives and/or comprehensive benefits. The actual base salary offered will depend on various factors, including the qualifications of the individual applicant for the position, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location of the position.Diversity Commitment: As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics as specified in applicable laws.
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