Quality Assurance Engineer II Position Available In Onondaga, New York

Quality Assurance Engineer II#25-61700
$40-$45 per hour
Skaneateles, NY
All On-site Job Description
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 Is a bachelor’s degree Required? YES How many years of recent experience does this person need to have? 2-4 Nice to Have Skills
1. Knowledge of Agile Product Lifecycle Management Tool
2. Knowledge of SAP Tool Onsite Role 5 days in Office

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.