Quality Engineer

Develops and implements quality control systems, inspects and tests products, and analyzes data to ensure products meet safety and quality standards such as ISO
13485, Medical Device Regulation 2017/745 (EU MDR), 93/42/EEC, MSDAP and the US Code of Federal Regulations.

The essential duties and responsibilities include the following. Other duties may be assigned.

• Review and Analysis Review and analyze requirements, specifications, and design documents to ensure full test coverage for lot release
• Test Planning Create comprehensive test planning documents for existing and new products
• Automation Develop and implement performance criteria for testing equipment and in process testing to meet specification requirements
• Defect Management Identify and document defects and evaluate improvements for changes to improve compliance with specifications and standards
• Documentation Maintain detailed records of all testing including defects
• CAPA Utilize the Quality System to ensure CAPA system is successful and compliant
• Document Control Responsible for Document Control of existing procedures and records, ensuring compliance with all applicable Standards and Requirements
• Auditing Internal and supplier audit training for EUMDR and ISO 13485
• Lot Release Review and ensure compliance in releasing and verifying DHR Lot release
• Data Analysis: Use statistical analysis and various software to analyze complex data and make data-driven decisions
• Provides QA support during third party audits
• Identifies deadlines and implements methods to comply with responsibilities in a timely fashion
• Ability to get along with others, follows directions, and works well under stressful conditions
• Responsible for following company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.