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Quality Assurance Systems Analyst
2 months ago
OrthAlign, Inc., a leader in innovative medical technology, is seeking a Quality Systems Specialist to enhance our quality management initiatives. This pivotal role involves conducting thorough investigations into nonconformities and ensuring compliance with industry standards.
Key Responsibilities- Conduct comprehensive investigations to identify root causes of nonconforming materials and processes.
- Oversee the Non-Conformance Management Report (NCMR) and Process Deviations protocols, providing support to stakeholders.
- Lead and manage Corrective and Preventive Action (CAPA) processes from initiation to closure, ensuring effectiveness checks are performed.
- Facilitate the CAPA program, guiding owners to meet deadlines and compiling performance metrics.
- Execute internal audits as per the established schedule and ensure findings are addressed promptly.
- Contribute to the development and revision of Standard Operating Procedures (SOPs) to uphold compliance and quality standards.
- Create and manage deviations, change orders, and CAPA documentation within the Quality Management System (QMS).
- Assist in external audit preparations, including FDA and ISO registrar audits.
- Provide support and troubleshooting for the electronic Quality Management System to internal stakeholders.
- Train new users on system functionalities and manage access permissions.
- Collaborate with IT to validate system updates and changes.
- Offer backup assistance 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 environment; or 6 years of relevant experience without a degree.
- Proficient in Microsoft Office365 applications 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 while maintaining accuracy.
- Strong written and verbal communication skills.
- Interpersonal skills to engage effectively with management and team members.
- Experience in conducting root cause analysis.
- Familiarity with quality processes and tools, including flow charts and fishbone diagrams.
- Experience with electronic quality management systems and document management systems.
- Competitive salary with bonus and equity opportunities.
- Career advancement potential.
- Comprehensive benefits package.
- A dynamic and engaging workplace culture.
Join OrthAlign and contribute to the future of medical technology.
