Hi Folks,


I have an opportunity of Validation Engineer with Medical device and
Manufacturing into Mechanical Domain if you came across anything into this
please let me know or else give me the reference where exactly I can get
this resource from I appreciate your help.



*Job title: Validation Engineer*

*Location: Irwindale, CA 91706*

*Duration: 6-12 Months Contract*



*Required Skills:*

Need to have Strong Process *validation* experience in *medical devices
industry.*

Strong medical devices industry experience.

*Mechanical* engineering background is Plus

3+ years of medical device process development experience in production
environment.

Degree in Mechanical Engineering - B.E / B.Tech / B.S / M.E / M.Tech / M.S

Knowledge of medical device design controls.

Performs and directs process validations, IQ, OQ, PQ, TMVs as required.

Oversees the validation program:  schedules, files, and records.

Administers validation training for the facility

Demonstrated knowledge of risk management techniques.

Interfaces with Quality and Manufacturing Engineers to review processes,
determine validation requirements, and coordinate the validation.

Demonstrated knowledge of CAPA process and root cause investigation.

Coordinates and performs testing relating to the validation.

Familiar with working within formal design control processes, writing test
protocols and reports.

Works with suppliers, management, Engineers, and Manufacturing Associates
in the resolution of quality problems associated with the validation
program.

Performs internal and external audits associated with validation
activities.

Utilizes advanced statistical tools to determine sampling plans and to
analyze data associated with validation activities.

Oversees and directs the activities of the Validation Engineers /
Technicians

Proven record of interpersonal skills to handle client, Result oriented and
self-driven.

Thanks and Regards
*Ethan Hunt*
*Agile Enterprise Solutions Inc*.
Phone: *630-242-8896 Ext:321* || Fax: 630-206-2397
E: *ethan_h...@aesinc.us.com <ethan_h...@aesinc.us.com>* ||
*http://www.aesinc.us.com
<http://www.aesinc.us.com>*

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