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Quality Assurance Systems Analyst
2 months ago
OrthAlign, Inc., a pioneering medical technology firm, is seeking a Quality Systems Specialist to join our dynamic team. This role is crucial in conducting thorough investigations into nonconformities and ensuring compliance with quality management standards.
Key Responsibilities- Conduct comprehensive investigations to identify root causes of nonconforming products and processes.
- Oversee Non-Conformance Material Reports (NCMR) and Process Deviations, facilitating containment actions.
- Manage and execute Corrective and Preventive Action (CAPA) processes from initiation to resolution.
- Coordinate the CAPA program, guiding owners to ensure timely compliance with procedural requirements.
- Perform internal audits according to the established audit schedule.
- Track and ensure the resolution of audit findings.
- Assist in the development and revision of Standard Operating Procedures (SOPs) to meet compliance and quality standards.
- Create and manage deviations, change orders, and CAPA documentation within the Quality Management System (QMS).
- Support external audits, including those from regulatory bodies.
- Provide assistance to internal stakeholders regarding the electronic Quality Management System.
- Train new users on system functionalities and manage access permissions.
- Collaborate with IT to validate system updates and changes.
- Offer backup support to the Document Control Specialist, including document numbering and change order processing.
- Bachelor's degree with a minimum of 3 years of experience in a medical device quality or operations setting; or 6 years of relevant experience without a degree.
- Proficient in Microsoft Office365 and PDF software.
- Strong knowledge of FDA regulations 21CFR820 and 13485:2016.
- Certification as a medical device auditor or equivalent experience is preferred.
- Ability to interpret and adhere to SOPs and comply with current Good Manufacturing Practices (cGMP).
- Exceptional organizational skills with the ability to prioritize tasks effectively.
- Strong written and verbal communication skills.
- Interpersonal skills to interact effectively with various levels of staff and management.
- Experience in conducting root cause analysis.
- Familiarity with quality processes and tools such as flow charts and fishbone diagrams.
- Experience with electronic quality management systems and document management systems.
- Competitive salary with bonus and equity opportunities.
- Career advancement prospects.
- Comprehensive benefits package.
- A vibrant and engaging workplace culture.
Join OrthAlign and contribute to our mission of innovation in medical technology.
