Manager, Quality

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  Lead the planning, preparation, review and approval of Quality Management Systems processes, procedures and related documents to ensure compliance with FDA GMP 21, CFR 820 and ISO 13485:2016 requirements.
• Provide quality assurance for new product development and design changes of FDA Class II and FDA Class III IVD products.
• Together with internal and/or external developers (ex. contract developers), manage the design control process and design history file documents supporting the design and development of FDA Class II and Class III IVD products.
• Provide input in design and development verification for demonstrating performance of IVD products meet requirements
• Responsible for implementing and maintaining the effectiveness of the quality system for in-vitro diagnostic (IVD) products by leading the Management Review process, CAPA and Audit systems.
• Interface with cross-functional teams at Sysmex Corporation in Japan and other Sysmex affiliates to ensure compliance with corporate quality management system and product design/development policies and procedures.
• Manage the planning and execution of internal audits, supplier audits and external agency audits. Interface with external auditors and inspectors regarding RDCA’s compliance activities.
• Completes quality indicator monitoring and assessments of quality system to verify compliance, identify potential gaps and execute process improvements.
• Maintain the document control and change control system.
• Manage quality training of RDCA employees.
• Other duties as assigned

Physical Risk. Regular exposures to risk that may require special training and precautions.

• Bachelor’s degree in Science required. At least 5 years of experience in quality assurance systems with at least 2 years of quality management experience.
• Certification as Lead Auditor to ISO 13485 and leading a Medical Device Single Audit Program (MDSAP) is preferred
• Experience participating in a regulatory audit is required
• Previous experience working in a regulated industry, preferably medical devices, in-vitro diagnostics or pharma, required
• Proficiency with Microsoft Word, Excel and Power Point
• Knowledge of implementation and maintenance of quality management systems
• Highly organized
• Excellent written and oral communication skills

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.