Quality Assurance Engineer II - CTQ

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.

Top 3-5 Must Have Non-negotiable Skills Required
1. Medical Device experience
2. Knowledge of ISO 13483 and 21 CFR 820.30
3. Experience writing Standard operating procedures (SOP s)
4. Strong writing and communication skills

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.