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 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 Eng Engineering, Mecha Eng Engineering, Mechanical Engineering or related field (willing to
accept for foreign education equivalent) plus three years of experience
planning, dev developing, executing, implementing, and providing quality
assurance sup support in FDA and ISO regulated medical device environment.
Experience mus must include: Three (3) years planning and executing design
controls for dev development of FDA and ISO regulated medical devices, including
user needs gat gathering, p gat gathering, product specification identification, design
verification and val validation, and design reviews; Three (3) years characterizing,
assessing, and and develo and and developing test plans for biocompatible products and
materials in New Pro Product D Pro Product Development and Sustaining Engineering initiatives;
Three (3) years dev developi dev developing risk management plans and reports, performing risk
evaluation of dev devices dev devices, and maintaining the risk management file in compliance
to ISO 149 14971; Two (2) years ensuring quality system compliance and
participating in in in in in internal and external audits; providing technical support to
product, pro process, or component related NCRs and CAPAs; and providing
guidance on EtO or or or or gamma irradiation sterilization assessments in New Product
Development and an and and Sustaining Engineering initiatives. Position requires 15%
domestic and int i int international travel. Qualified candidates please send resumes to: Devicor Medical
Products, Inc. A A Attn: Allison Carl at 300 E. Business Way, 5th Floor,
Cincinnati, Ohio 4 45241 and reference job title.
Keywords: Devicor Medical Products Inc., Fairfield , Senior Quality Engineer, Engineering , Cincinnati, OH , Ohio
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