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Manager – Quality and Regulatory Affairs

ComplianceComplianceFull TimeRemoteTeam 201-500Since 1986H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

146 days ago

Salary

Not specified

Bachelor Degree5 yrs expEnglish

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.

Job 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.