Risk Quality Engineer (Design Controls)

Job Title – Risk Quality Engineer (Design Control)
 
Job Location – Gainesville FL
 
Length – Contract (11 Months+)
 
Must have experience working in the medical device industry. 
 Must have ENISO 14971:2012 experience. 
 Must have Full understanding of Risk Management, in particular ENISO 14971:2012 
 Must have Full understanding of Design controls in accordance with 21 CFR QSR 820 
 
Job Description:
 Provide support in the development, release, and maintaining product risk file in accordance with ENISO 14971:2012 and internal Philips procedures. Support involves:
 
 1. Creation of new risk files for currently released products. This includes plans and reports.
 2. Updating any in process product risk files to new risk process requirements.
 3. Interfacing with Regulatory, Clinical, and Engineering personnel as a team to complete risk remediation on time.
 4. Will provide design control support if required to meet objectives.
 
 Skills and Education
 Must have experience working in the medical device industry. 
 Must ave ENISO 14971:2012 experience. 
 Full understanding of Risk Management, in particular ENISO 14971:2012 
 Full understanding of Design controls in accordance with 21 CFR QSR 820 
 Familiar with ISO 13485: 2016 
 Have technical writing skills. 
 Be able to use MS word & Excel. 
 
 Education: Degree in Mechanical, Electrical, or Software Engineering. BS or higher
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com
609-357-9180 (Direct)

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