Quality Engineer

Summary:

Will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files.

Roles & Responsibilities:

Provide Quality expertise in Product Development, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files. Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA). Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional. Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes. Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions. Coordinate product testing with internal and external laboratories as required. Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.

Education & Experience:

Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary. Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects. Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations. Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook ). Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting) Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485). Position requires up to 15% travel. At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.