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Quality Systems Engineer - Medical Devices

Location : East Hanover NJ US 07936
Job Type : Temp/Contract
Reference Code : 19248-BZ1
Compensation : open - 40-50/h
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Contract position for a Quality Systems Engineer to catalogue and maintain quality system documentation and records involving design projects, supply chain records, and various quality systems documents.

  • Participate on cross functional product teams for the development of new and modified orthopedic system.s

  • Assist with the development of the design history file (DHF) and all included records.

  • Collect, scan, and retain new and revised quality documents of various file types (MS Excel, MS Word, pdf).

  • Ensure that current and correct documents are available for use where needed including suppliers, and the removal of old and obsolete versions from use.

  • Maintain hard copy records and computer database of all filed documentation that ensures fast sorting and retrieval of documents and records.

  • Maintain document control logs for tracking quality system statistics

  • Perform periodic documented examination and verification of activities, records, and processes of any given quality system to determine the effectiveness and dependability of such system.

  • Evaluate internal processes and results comply with the requirements of procedures, quality, and regulatory requirements.

  • Participate in quality audits, identify gaps and issues where a department is meeting requirements, as well as identify opportunities for improvement.

  • Responsible for CAPA system management including tracking, processing, approval and documents required to initiate closure of CAPAs.

Required Qualifications :

  • BS Engineering or Science

  • Minimum 5 yearss experience in the Medical Device field.

  • Knowledge of FDA Quality Systems Regulations and International ISO quality systems standard.

  • Computer skills including Microsoft Office, Adobe Acrobat, internet cloud sharing, PDM systems.

  • Ability to communicate, interact and work effectively and cooperatively with all people including those from diverse ethnic and educational backgrounds.

Contact: Bill Zukowsky

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