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OVERALL DESCRIPTION
Responsible of chain of command set-up, of Risk Management stemming from client complains and of the validation process. Supports new product launch, transference and changes in existent products. Conducts and supports improvement activities for products and processes.

MAIN FUNCTIONS AND RESPONSIBILITIES:

• Supports investigations on client complains.
• Conducts the distributed product risk analysis (DPRA) stemming from client complains
• Prepares presentations and conducts the QLT chain of command meetings related to client complains.
• Gives support to investigations and CAPA approvals.
• Reviews and approves QSNCs.
• Reviews and approves CRs and DCRs related to FMEAs, Manufacturing Quality Plans and Supplementary Specifications
• Reviews and maintains FMEAs and Manufacturing Quality Plans for the processProvides additional information for FDA reports
• Participates in transfer and change of products and processes.
• Works with NPD and with the manufacturing, process engineering and manufacture engineering departments to develop, conduct and approve engineering studies DOE, FMEA, MQP, TMV, strategies, protocols, and reports for the validation of products and processes.

• Participates in Error Proofing projects
• Supports activities for the improvement of process capacity
• Develops and supports PE, CPIP and Kaizen projects
• Supports ME2 activities
• Supports activities related to facilities and clean room
• Notifies changes and provides direction in solving problems
• Actively participates in MRB metrics revision meetings
• Supervises and develops quality engineering
• Answers to internal audit observations related to the functioning of quality engineering
• Complies with company regulations, local, state or federal, as well as procedures and policies for safety and hygiene, health and environment.

POSITION REQUIREMENTS

• Knowledge higher tan basic in the theoretical foundations of engineering and experimental techniques
• Good abilities to communicate in spoken and written English
• Ability to use a personal computer and associated software

• Seven to nine years of experience with professional studies; three to seven years with a Masters Degree; up to four years of experience with a PhD or an equivalent combination of experience and training.
• License or certification in the specified discipline (preferable)
• Medical Device Industry Experience

• Engineering studies
• Master’s Degree studies (preferable)

More info: http://www.empleosmaquila.com/viewjobpre.asp?JobID=17087