46450-4747 - Quality Engineer

Location: Grand Rapids
Posted on: January 14, 2021

Job Description:

Requisition # : 46450-4747
Start Date : 11/24/2014
End Date : 2/24/2015
Over Time Allowed : No
Interview Type : Phone Interview
Travel : No Travel Required
Environment : Professional
Schedule : 8 - 10 hour professional day
Dress Code : Business Casual
Work Location : Grand Rapids, MI 49504
Labor Category : Engineering
Job Family : Manufacturing/Engineering
Job Title : Quality Engineer

Job Duties :
-Design of Experiments (DOE) and Statistical Process Control (SPC)
-Determines manufacturing operation requirements and process parameters
-Develops and implements strategic plans
-Develops plans to evaluate process repeatability and stability
-Supports manufacturing, development, and implementation processes
-Utilizes FMEA within process development
-Ensures compliance with GMP's
-Generates documentation for engineering protocols and reports
-Implements quality system improvements
-Writes engineering and manufacturing specifications

Required:
*Education Level: Undergraduate Degree
*Industry Experience: 3 - 5 Years
*Oral Communication: Excellent
*Project Management : Project Recordkeeping and Documents
*Written Communication: Excellent

Request Notes :
*Quality engineer with Medical Device experience capable of resolving outstanding CAPA and FMEA calibration
*Looking for 5+ years of experience Working at small medical device sterilization facility.
*No Quality Engineer on site.
*Need someone to drive quality system forward.
*Knowledge of ISO 13485 Quality System required.
*The person will be investigating issues, revising procedures to ensure compliance to standards.
*Writing protocols and reports
*Equipment IQ/OQ/PQ.
*Must be able to work on a team with good communication both up and down.
*Good documentation skills.
*Ability to communicate with customers both verbally and in writing.
*Ethylene dioxide sterilization experience is preferred

If you are interested in this opportunity and you qualify please complete the following and send back with your updated resume.
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Requirement #: 46450-4747
Your resume in Word format along with your salary requirements to rsanderson@keystonecs.com

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