Job Description

Job Code: #10436
Title: Quality Engineer
Date Posted: 07/15/2019
Job Location: Malden MA

Job Description:

Senior Quality Engineer

Description: Collaborates with the engineering team on design and development helping to bring new products to market and ensures compliance throughout the product lifecycle by participating in dFMEA, aFMEA, pFMEA meetings, and requires a thorough knowledge of 21 CF 820, ISO 13485, ISO 14971 standards and risk management principals. Contributes to design verification and/or validation, as well as IQ/OQ/PQ activities and perform reliability analysis and develop risk-based sampling plans using various statistical analysis tools. Manages the Quality Inspection team and junior Quality Engineers. Participates in the Material Review Board (MRB) and analyzes NCMR trend data. Conducts first party and second party quality system audits.

Minimum Requirements: Master’s or Bachelor’s plus 5 years’ experience in Biomedical Engineering related or equivalent


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