Implements, revises and maintains quality standards for processing materials into partially finished and finished medical devices and subsystems. Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment, prepares documentation for inspection testing procedures in accordance with ENISO 13485, MDD, and ISO 9001.
Provides quality system and product audits.
Formulates or assists in formulating quality assurance policies and procedures. Develops and institutes standards and methods for inspection testing and evaluation for assigned products. May recommend major changes in procedures.
Plans and implements quality testing for systems, assemblies, components and purchased items, provides test and inspection procedures for quality control personnel.
Directs and trains engineering and manufacturing personnel in the use of and adherence to quality standards. Confers with manufacturing, materials, engineering and quality control personnel to ensure that quality procedures are followed. Interfaces with suppliers and ensures that quality standards are met.
Prepares quality reports on assigned products or components for use by engineering and management personnel.
Analyzes reports of returned products and recommends corrective action. Interfaces extensively with customers to identify and resolve technical quality issues.
Provides technical support to engineering, test engineering and manufacturing departments. Participates in design reviews during new product introduction. Analyzes production limitations and standards and may recommend revision of specifications when indicated.
Assignments are complex in nature and require independent action and decision-making. Generally assigned to one or more projects with high level of technical complexity and/or financial impact.
Performs other duties as assigned.
BSEE or equivalent and ten or more years of related experience. Six Sigma certification preferred.