New 
USA - Quality Assurance Engineer II - CTQ
 Equiliem | |
 United States, New York, Skaneateles | |
 Jun 13, 2025 | |
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Job Summary:
We are seeking a Systems or Quality Engineer to be responsible for integrating design procedures, templates, and guidance documents within our ISO 13485 compliant Quality Management System (QMS). The successful candidate will have a working knowledge of FDA/ISO regulations, specifically ISO 13485 (7.3) and 21 CFR 820.30, and the application of Good Documentation Practices. Demonstrate ability in writing quality system procedures. The ideal candidate will have a demonstrated ability to communicate with a wide range of stakeholders, including Quality, Systems/Risk, Project Management, Regulatory Affairs, Marketing, and others. Position Responsibilities: * Complete SOP gap assessments for process integration focused on the Front Line Care division. * Participate in 'deep dive' reviews of selected procedures with Subject Matter Experts (SMEs). Ensure that process details driven by prior corrective actions are reviewed and maintained as appropriate. * Write/update, review, analyze, and revise Standard Operating Procedures (SOPs), work instructions, forms, templates. * Drive reviews/approvals of SOPs with cross functional Subject Matter Experts (SME's). * Monitor actions for proper SOP implementation. * Report periodic integration status to stakeholders. * Work with different functional groups and produce appropriate documentation in support of SOP integration. * Strong verbal and written communication skills, documentation practices, be self-motivated and possess strong interpersonal skills. * Excellent problem-solving skills and attention to detail. | |