Hi Folks*,*

*Greetings of the Day!!!! *

This is very fast moving  position  with one of my Client , So please let
me know if you have a good fit consultant , Please provide me his/her
resume with contact detail and send it to me at *[email protected]*
<[email protected]> or give me call at 408-709-1760 EXT- 925

*Position: Mechanical Engineer (**Process validation)*

*Location: **Irwin dale, CA*

*Duration:  Long term*



*Mandatory Skills:*

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

§  Strong *medical devices industry* experience.

§  Need to have *Mechanical engineering background*.



*Required skills:*



§  5+ 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.

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