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.

Responsibilities

• Review and analyze requirements, specifications, and design documents to ensure full test coverage for lot release
• Create comprehensive test planning documents for existing and new products
• Develop and implement performance criteria for testing equipment and in‑process testing to meet specification requirements
• Identify and document defects and evaluate improvements for changes to improve compliance with specifications and standards
• Maintain detailed records of all testing including defects
• Utilize the Quality System to ensure CAPA system is successful and compliant
• Responsible for Document Control of existing procedures and records, ensuring compliance with all applicable Standards and Requirements
• Conduct internal and supplier audit training for EU MDR and ISO 13485
• Review and ensure compliance in releasing and verifying DHR lot release
• Use statistical analysis and various software to analyze complex data and make data‑driven decisions
• Provide QA support during third‑party audits
• Identify deadlines and implement 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