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 ISO13485, Medical Device Regulation 2017/745 (EU MDR), 93/42/EEC, MSDAP and the US Code of Federal Regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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.