Manager – Quality and Regulatory Affairs

Job Description: • Administrative Support – scheduling meetings, preparing reports, and maintaining audit and CAPA schedules. • Audit Support – prepare for internal and external quality audits by organizing documentation and ensuring compliance with relevant standards (ISO 9001 and ISO 27001) and HIPAA and GDPR regulations. • Process Support – Assist in implementing and monitoring quality processes and systems to ensure they meet organizational standards and objectives. • Training and Compliance - Manage internal employee training in the STARlearn (LITMOS) system, provide data on training completion rates, create training modules as needed, and ensure training is completed promptly. • Data Collection and Analysis – Gather and organize quality-related data to support internal audits, management reviews, and continual improvement efforts. • Continual Improvement – participate in projects aimed at improving the efficiency and effectiveness of the quality and information security management systems. Requirements: • 5 -10 years of experience working with ISO 9001:2015 and ISO 27001:2022 standards, either as an internal or external auditor or Quality Assistant. • Certification with ASQ or Exemplar Global is a plus. • Self–starter – must be able to work with minimal supervision, pro-active, open to new concepts, and engage with others without prompting. • Attention to Detail – must be meticulous in work approach to ensure accurate record-keeping and quality control. • Organizational Skills – Must be able to manage multiple tasks, documents, and projects without reminders. • Computer Proficiency – MS Office Suite, SharePoint, Salesforce, LITMOS LIMS, Zendesk. • Problem solving – must be able to identify minor issues and contribute to finding solutions. Benefits: • Competitive health and Wellness (medical, dental, and vision) • Retirement plan with matching company contribution • Life Insurance and Disability/Income Protection Apply tot his job