Description: Our client is currently seeking a Specialist, Quality Assurance for a 12 month + contract.
Primarily responsible for facilitating document and product related changes in accordance with change management procedures and relevant regulatory requirements for medical devices.
Key areas of responsibility • Facilitate the change management process for document and product related changes. • Perform administrative activities related to learning management system. • Assist with the migration of QMS related documentation from local document management systems to PLM system (Windchill). • Ensure QMS documentation reflects actual business activities while remaining compliant with applicable internal and external regulatory requirements including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR and individual country requirements. • Drive Good Manufacturing Practices and Good Documentation Practices. • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS and associated documentation. • Develop and deliver training for QMS areas of expertise. • Engage the IT team in relevant PLM system discussions.
Education / work experience:
• BS in a science, engineering, business or related discipline.
• Minimum of 3 years experience in a regulated industry using electronic document/change management systems preferred.
Knowledge / competencies
• Fluent in English and French
• Proficient in Microsoft applications including but not limited to Word, Excel, Power Point, etc.
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Ability to plan, organize, and implement multiple concurrent tasks.
• Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
• Demonstrated ability to work in cross-functional team environments.
• Basic understanding of compliance risk situations.
Contact: eronan@judge.com
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