What are the responsibilities and job description for the Sr. Specialist QMS - SII position at Sysmex?
Overview
Find a Better Way...
...to use your skills and experience.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
...to improve the lives of others.
Headquartered in Kobe, Japan, Sysmex Corp. is renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems. We apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
Sysmex Inostics, a subsidiary of Sysmex Corp. is a molecular diagnostics company that is a pioneer in blood-based cell-free tumor DNA testing in oncology. Our highly sensitive OncoBEAM™ and SafeSEQ technologies can detect minute amounts of mutant DNA circulating in the bloodstream. With these technologies we support clinical researchers and oncologists with therapy selection and monitoring of response, recurrence as well as resistance.
Responsibilities
...to build a promising future.
Responsibilities
We currently have a great opportunity for a Senior QMS Specialist. The Senior QMS Specialist leverages skill in efficient, regulation guided processes, assessments, and process improvements to further improve quality functions, formalized procedures, operations, and systems. The Senior Specialist is a high visibility QMS support role, responsible for ensuring compliance to quality standards per regulations and making recommendations to improve the quality of processes, products and services.
The Senior Specialist ensures continued compliance with CLIA, CAP, ISO 15189, ISO 13485, FDA, and other applicable regulations.
Essential Duties and Responsibilities:
1. Assist in all aspects of the full operation, implementation, and maintenance of the Quality Management System (QMS) to ensure continued compliance with Clinical Laboratory Improvement Amendments of 1988 (CLIA), College of American Pathologists (CAP), and the FDA.2. Act as a change agent for QMS, inclusive of our company culture and leadership behavior.3. Support and oversee existing and future QMS application systems (e.g. electronic solutions and digitization).4. Support internal and external audits and inspections to provide input and where needed help communicate direction to respond to observations and ensure appropriate changes are implemented.5. Actively communicate with the various areas and departments to identify areas of improvement.6. Assist with implementation of new processes to streamline current business and system practices to regulatory compliance with key stakeholders and department leaders.7. Create, review, and approve documents including Standard Operating Procedures, Quality Metrics Reports, Management Review and other regulatory compliance documentation.8. Provide support and contribute to other QA activities as needed.9. Work and interact cross-functionally with a variety of teams to foster a solution - focused approach to opportunities.10. Other duties as assigned.
Physical Risk: Regular exposure to risk that may require alertness, but with minimal precautions.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Qualifications
Bachelor’s degree in science, engineering, business, or related areas of study required. Previous experience in GXP required. 5-7 years in regulatory environment (experience in GXP roles)
Experience & regulatory expertise of industry quality systems/standards
Ability to interpret applicable regulations/standards
Experience in leading process improvement initiatives
Ability to communicate and negotiate internal stakeholders effectively
Sysmex’s COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual’s ability to provide proof of current vaccination status. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
