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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., Lawrence , Senior Quality Engineer, Engineering , Cincinnati, OH, Indiana

Click here to apply!

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