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Quality Engineer - Medical Devices

Location : Valley Cottage NY US 10989
Job Type : Temp/Contract
Reference Code : 20690-BZ1
Compensation : open - 30-35/h
Start Date : 10/22/2021
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Contract position for a Quality Engineer for Medical Device manufacturing.

  • Responsible for product rework, engineering changes, corrective actions and review and approval of test reports.

  • Responsible for quality system audits to ISO 9001 / ISO 13485 standards.

  • Translates quality requirements into quality assurance plans and instructions.

  • Prepares and implements quality standards, operating procedures, work instructions and reporting systems.

  • Reports in-house and field quality data and quality problems, recommends corrective action, and verifies effectiveness of solutions.

  • Conducts internal quality and vendor audits on a scheduled basis.

  • Performs other duties as assigned.

Required Qualifications :

  • BS - Engineering or equivalent experience with Quality Engineering for medical device manufacturing.

  • Minimum 3 years experience in a supervisory role for quality assurance or regulatory affairs

  •  Experience with ISO-13485 or similar quality system standard and quality auditing.  

  • External advanced QSR/GMP/ISO training and related SOP training. 

  • Experience with test reports and engineering changes.

  • Experience with Corrective and Preventative Actions (CAPA).

Contact:  Bill Zukowsky 

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