Senior Quality Engineer
Company: Devicor Medical Products, Inc.
Location: Cincinnati, OH
Posted on: January 24, 2019
Job Description:
Duties: Apply biomedical engineering principles to execute the
Quality Engineering function for medical devices. Ensure product
compliance to 21 CFR Part 820, ISO 1348 : 2016, ISO 14971: 2007, and MDD
93/42/EEC. Collaborate with cross-functional teams including Design
Engineering, Systems Engineering, Regulatory, Program Management, and
Marketing to maintain adherence to Devicor's Quality Management System during
planning, execution and implementation activities for New Product
Development and Sustaining Engineering initiatives. Lead the development and
enforcement of Devicor Devicor Medical Products' risk management activities to ensure
patient and user safety through identification of risk-driven product
requirements, generation of risk management report/benefit analyses, and
participation in post-market product surveillance. Requirements: Master's degree in Biomedical Engineering,
Material Science Engineering, Mechanical Engineering or related field (willing to
accept foreign education equivalent) plus three years of experience
planning, developing, executing, implementing, and providing quality
assurance support in FDA and ISO regulated medical device environment.
Experience must include: Three (3) years planning and executing design
controls for development of FDA and ISO regulated medical devices, including
user needs gathering, product specification identification, design
verification and validation, and design reviews; Three (3) years characterizing,
assessing, and developing test plans for biocompatible products and
materials in New Product Development and Sustaining Engineering initiatives;
Three (3) years developing risk management plans and reports, performing risk
evaluation of devices, and maintaining the risk management file in compliance
to ISO 14971; Two (2) years ensuring quality system compliance and
participating in internal and external audits; providing technical support to
product, process, or component related NCRs and CAPAs; and providing
guidance on EtO or or gamma irradiation sterilization assessments in New Product
Development an and Sustaining Engineering initiatives. Position requires 15%
domestic and in international travel. Qualified candidates please send resumes to: Devicor Medical
Products, Inc. At Attn: Allison Carl at 300 E. Business Way, 5th Floor,
Cincinnati, Ohio 45 45241 and reference job title.
Keywords: Devicor Medical Products, Inc., Louisville , Senior Quality Engineer, Engineering , Cincinnati, OH, Kentucky
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