Job Description
Job Description:
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.
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, analyse, 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.
Requirements:
- Is a bachelor’s degree Required? YES.
- How many years of recent experience does this person need to have? 2-4.
- Medical Device experience.
- Knowledge of ISO 13483 and 21 CFR 820.30.
- Experience writing Standard operating procedures (SOP’s).
- Strong writing and communication skills.
- Knowledge of Agile Product Lifecycle Management Tool.
- Knowledge of SAP Tool.