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Quality Assurance Engineer
Medical Device/ISO 13485/FDA
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Location: North, MO
Pay Rate: Contract: 35 to 40.50 $/hr
Salary: 72.80 to 84.24 K$/yr
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Position Type/ Job Duration: Contract 3 - 4 months
Education Required: BS Engineering/Technical 
Years Experience Required: 5

Industry:
Medical
Job Posted: 12/11/2017
Should I worry about this date?
Apply Deadline: 01/14/2018
Job #: 134862MKK
Job order status: Client is actively seeking candidates
Relocation available: Not Available


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Medical Device Regulatory Quality Assurance Engineer is needed to ensure compliance to regulatory requirements ISO 13485, EN ,EMDD, CMDR, and other associated or applicable standards. Requires BS Technical and 5 years experience in Quality Management and Regulatory Affairs, medical device manufacturing, FDA (CFR 820) and ISO/EC requirements, statistics and sampling methods. This is a Contract to Direct Hire position in Missouri.

Responsibilities

  • Establishes documentation required for the implementation and maintenance of quality systems and compliance to applicable International standards, such as ISO13485, ISO 17025, 21 CFR 820, MDD 93/42/EEC, SOR/98-282, J-GMP (i.e., PAL)
  • Supports administration of Project Management, Design Control, Research, Development & Engineering efforts within the facility.
  • Provides liaison between the operations management and applicable regulatory agencies regarding audit findings, litigation, and complaints.
  • Establishes and implements quality systems that will support the key strategies for the plant with emphasis on continuous value improvements in total cost, quality, service, and innovation.

Requirements

  • BS Technical and 5 years experience in Quality Management and Regulatory Affairs, medical device manufacturing, FDA (CFR 820) and ISO/EC requirements, statistics and sampling methods.
  • Six Sigma Engineer or ASQ Certification in Quality Engineering or Quality Management

Benefits

  • Insurance, 401K,PTO
 
 
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Related Keywords medical device, compliance, regulatory, quality, quality assurance, iso13485, iso 17025, 21 cfr 820, mdd 93/42/eec, sor/98-282, j-gmp, pal, iso 13485, en ,emdd, cmdr
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