Quality Assurance Specialist
2 weeks ago
We are seeking a Quality Assurance Specialist to join our team at Sterling Engineering. As a Quality Assurance Specialist, you will play a key role in maintaining and improving our Quality Management System (QMS).
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
- 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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Quality Assurance Specialist
2 weeks ago
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