Description

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. The essential duties and responsibilities include the following: 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 compliance with specifications, maintain detailed records of all testing including defects, utilize the Quality System to ensure CAPA system compliance, responsible for Document Control of existing procedures and records, conduct internal and supplier audit training for EUMDR 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. Provides QA support during third-party audits, identifies deadlines and implements methods to comply with responsibilities in a timely fashion, and follows company policies and procedures, including Quality System Regulations, safety/housekeeping, and Quality Management System.

Requirements

Bachelor’s degree required. 2 – 5 years’ related work experience. Medical device experience and customer service experience required. Six Sigma black belt preferred. Must understand and know how to navigate a CAPA through the Quality System. Working knowledge of ISO 13485, 21 CFR Part 820.100. Experience in computer/database applications, proficiency in Microsoft Outlook, Word, and Excel. Ability to speak, read and write English, bilingual in Spanish a plus. Ability to work with minimal supervision. Excellent written and verbal communication skills. Strong analytical and problem-solving skills. Strong project management and organizational skills. Excellent attention to detail, resourceful, self-reliant, self-motivated and confident. Ability to multi-task and adjust to frequent changes. Ability to be tactful, discreet and handle confidential info appropriately.

Quality Engineer

Description

Requirements

Retractable Technologies