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03-29-2004, 04:50 AM
Small medical device manufacturer seeks Quality Control Engineer/Manager.

*Maintain quality level of product and service for Kinamed. Insure only
product conforming to specification is released to stock.

*Good organization, administration and communication skills, meet schedules.

*Interface with all departments internally, and customer, subcontractor and
regulatory agencies externally.

*Maintain Quality Manual and Quality SOP’s.

*Implement cGMP’s, ISO and EN requirements.

*Develop procedures, material and process specifications including
sterilization requirements.

*Develop inspection criteria for Kinamed’s product and processes.

*Develop validation criteria for Kinamed’s processes. To include
software validation and sterilization.

*Incorporate OEM customer’s specification into Kinamed process, develop
inspection criteria and tooling and validate processes.

*Responsible for the internal and external audit program and insuring audits
are performed and preventative and corrective action is taken.

*Interface with subcontractors and monitor their performance through audits
and analysis of subcontractor data. Maintain “Nonconfirming Material
Reports,” data input, quarterly analysis and reports to management.

*Responsible for product complaint handling, investigation, analysis,
trending and reporting. Interface with engineering, marketing, operations
and customer service during investigation and report findings to executive

*Responsible for the Quality Training Program – establishing and
conducting training.

*Responsible for handling quarterly and yearly process validation testing,
data analysis, and reports to executive management

*Responsible for Kinamed Safety Program and training.

* Minimum 2 years as Quality Engineer.
* Supervisory/Management experience.
* Experience in the medical device field.
* Computer proficiency.
* Experience with ISO and EN standards.

* Minimum 4 year technical degree or 2 year technical degree and ASQ
Engineering Certification.
* Fluent in speaking, reading and writing English.

If interested and qualified, PLEASE DO NOT REPLY TO SENDER.
Email or send cover letter and resume to:
Kinamed, Inc.
820 Flynn Road,
Camarillo, CA 93012,

Kinamed is an equal opportunity employer.

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