Risk Management Associate

Position Summary: The Risk Management Associate is responsible for overseeing Failure Mode and Effects Analysis (FMEA) projects and administration of Risk Management projects in compliance with applicable standards and internal procedures.

 

Essential Job Functions:


* Oversees FMEA projects by performing the following: facilitates interaction of cross-functional teams for FMEA meetings, guides entry of FMEA information into Risk database, provides insight into content and failure modes, and performs tracking and control of FMEAs.


* Oversees Risk Management projects by performing the following: coordinates movement of FMEA information to Risk Management, facilitates interaction of cross-functional teams for Risk Management meetings, guides entry of Risk Management information into Risk database, and provides insight into content and compliance with ISO 14971.


* Assists in tracking and controlling of Risk Management Files.


* Oversees use of the Risk database including the transfer of legacy FMEA and Risk information into the database, assists in the modernization of Risk Management Files using the Risk database, participates in the maintenance of the Risk database by ensuring consistency of data and best practices across departments/projects.


* Supports regulatory compliance activities by applicable government agencies and certifying bodies.

This includes ensuring compliance to applicable standards and regulations with regards to Risk Management.


* Supports Quality interactions with Design Control activities through FMEA and Risk Management projects.

Actively participates on new product and reengineered product implementation teams.


* Assesses and, as needed, revises Quality and Regulatory Compliance SOPs and processes.


* Follows all company environmental, health and safety policies, procedures and guidelines, and conducts work in a safe manner.


* Performs other duties as assigned.

 

Job Specifications (skills, knowledge, special training, certification, license requirements):


* Thorough working knowledge of FDA Quality System Regulations (QSR – 21CFR820), ISO 13485/ ISO 14971 standards and other relevant QMS and regulatory compliance requirements


* American Society for Quality (ASQ), Regulatory Affairs Professionals Society (RAPS) and other relevant professional certifications desired


* Familiarity with Risk Management and FMEA concepts


* Experience leading cross-functional team meetings preferable


* Excellent computer skills including word processing, spreadsheets and database software essential


* Strong leadership skills required


* Excellent written and oral communication skills required


* Must be detail-oriented and thorough


* Excellent organizational skills and the ability to balance multiple projects and priorities; familiarity with Project Management concepts preferable


* Ability to manage fast-paced, deadline-oriented activities

 

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