Quality Engineer

Company: SPR Therapeutics, Inc.
Location: Cleveland
Posted on: May 16, 2022

Job Description:

Quality (or Senior Quality) Engineer SPR Therapeutics, headquartered in the Highland Hills/Beachwood area, is a growing, medical device development company specializing in pain management through non-narcotic means. We are adding an experienced medical device industry Quality Engineer or Senior Quality Engineer to support the design and development of product enhancements as well as innovative new products that are intended to improve patients--- lives. Some responsibilities of the Quality Engineer: -- Ensures product development activities are conducted in accordance with FDA---s QSR, ISO 13485 and internal Quality System requirements. -- Supports cross-functional development project teams to ensure that new products and product changes are adequately evaluated/tested with respect to requirements and the product Design History File is complete. -- Develops and maintains risk management files through active participation in risk management activities from product conception through commercialization. -- Supports the needs of contract manufacturers and product release activities. -- Contributes to sustaining the quality management system and the software on which it is run, including validating routine software updates. -- Supports and/or leads internal and external audits, product complaint processing, CAPAs, and nonconformances. Requirements: -- Bachelor---s degree in Engineering. -- 5-10 years of Quality Engineer experience in medical device industry. -- Strong self-starter, effective team player, and detail-oriented required. -- Understanding of US medical device regulatory compliance requirements (ISO 13485 and FDA---s QSR). -- An effective oral and written communicator with the ability to lead meetings and clearly present ideas to employees and other stakeholders. -- Ability to work efficiently and creatively in a regulated industry. Why Join Our Team? -- Entrepreneurial work environment --- A growth oriented and collaborative atmosphere in the medical device industry -- Ability to work with game changing technology. -- Competitive compensation and benefits -- Employee Wellness Program

Keywords: SPR Therapeutics, Inc., Cleveland , Quality Engineer, Engineering , Cleveland, Ohio