Quality Assurance Specialist (Quality Management System) - Medical Device
The QA Specialist will play a key role in maintaining and improving our Quality Management System (QMS). The primary focus will be on documentation, ensuring compliance with relevant standards like ISO 13485, and supporting quality assurance activities across the organization.
This role requires a detail-oriented, process-driven individual with experience in quality engineering and validation.
Key Responsibilities :
- Develop and revise procedures, work instructions, and forms to clean up and maintain the Quality Management System
- Ensure that documentation aligns with ISO 13485 and Good Documentation Practices (GDP) where applicable
- Format, organize, and maintain documentation and file structures
- Work independently to interview staff and gather necessary information for documentation updates
- Create training materials and presentations using Word, Excel, and PowerPoint
- Lead efforts in validation and commissioning as needed
- Collaborate with cross-functional teams to ensure quality standards are met
- Support continuous improvement initiatives in quality and documentation processes
Qualifications :
- Strong experience in quality assurance, preferably in a production or manufacturing environment
- Familiarity with ISO 13485 standards (or other similar standards), with the ability to work independently under these guidelines
- Experience in creating and formatting technical documents, work instructions, and procedures
- Proficiency in Microsoft Word, Excel, and PowerPoint, with experience in creating training materials
- Strong organizational skills and attention to detail, especially in document management
- Knowledge of validation processes and Good Documentation Practices (GDP) is a plus
- Ability to work both independently and collaboratively, with strong interviewing and communication skills
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