At SEKISUI Diagnostics, a leader in in vitro diagnostics, we help improve patient outcomes by doing what we’ve always done – 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 show case 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 generation and review of documents used in good manufacturing practices. Also monitors audits of production and quality control areas. May audit raw material vendors and prepare manufacturing documentation for updated filing. Coordinates interdepartmental activities. May lead investigations and resolve potential product quality issues to improve efficiency. Selects, develops and evaluates 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 doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can 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. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.   

SEKISUI Diagnostics offers a competitive compensation.  

Equal Opportunities   

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, other non-job-related characteristics or other prohibited grounds specified in applicable country and local laws. It is also SEKISUI Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.  SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the Company’s internal recruiting team.   

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 a variety of factors, including without limitation, 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.