Robling Medical

Robling Medical, Inc.
90 Weathers Street
Youngsville, NC 27596

+1-919-570-9605

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  • Medical Products Design & Manufacturer, Youngsville, NC

    Manufacturing Services

  • Medical Products Design & Manufacturer, Youngsville, NC

     

    12,000 square feet

    of Cleanrooms

  • Medical Products Design & Manufacturer, Youngsville, NC

    Electro-Mechanical

    Assembly &

    Testing

  • Medical Products Design & Manufacturer, Youngsville, NC

    Sterile Barrier

    Packaging

Quality Assurance Engineer

General Summary

Responsible for serving as a member of a Cross Function Customer Focus team and assisting the Director of RA/QA in the maintenance of the Quality Management System. Responsible for assuring compliance with Quality System Procedures through the support of QA personnel.

Primary Duties and Responsibilities

  • Assist in the development and review of Purchasing Specifications and receiving inspection criteria as new products are brought on line.
  • Responsible for gaining a comprehensive understanding of the manufacturing process prior to transfer to manufacturing and for assisting in the transfer to manufacturing through training of QA inspection and manufacturing personnel.
  • Develop and maintain verification and inspection procedures, methods, and sampling plans to assure customer requirements and product specifications are met.
  • Lead in the development and maintenance of Limit Samples and other inspection aids and training tools
  • Lead all Risk Assessment activities (PFMEAs and DFMEAs)
  • Lead QA Specialists in the Nonconforming Materials Control Process by assuring non-conformances are investigated, controlled, documented, resolved and closed in a proper and timely manner
  • Perform investigations and document findings related to Corrective Action and Preventive Actions that are initiated. Performs follow-up verifications after CAPA Plans are implemented
  • Evaluate, summarize and report on quality data and Key Performance Indicators to assure problems are being adequately addressed and there are no indications of trends or system breakdowns.
  • Provide support to other Managers and Engineers related to Cost Savings and continuous improvement Initiatives
  • Provide interface and communications with customer and suppliers on all quality concerns.
  • Develop and maintain training modules and training effectiveness assessments related to quality procedures and practices
  • Review and approve Validation Protocols and Reports
  • Assist in the execution of Validation activities as required.
  • Interfaces with Suppliers regarding incoming quality issues
  • Performs Supplier Audits
  • Conducts Internal Audits
  • Guidance and oversight on non-conforming materials, including re-work
  • Other duties as assigned

Required Qualifications

  • 4 year BS degree or equivalent applicable experience
  • Proficient in the use of Quality Management Tools
  • Proficient in Microsoft Office Suite
  • Strong writing skills
  • Strong verbal communications skills
  • Proficient in interpretation of regulatory requirements and standards
  • Strong Analytical skills – Cause and Effect Analysis

Preferred Qualifications

  • ISO 9001 or ISO 13485 Certified Auditor
  • Experience in the performance of Supplier Audits / Evaluation
  • Experience in the appropriate selection of Statistical Tools

Environment & Working Conditions

  • Lifting – 30 lbs
  • Ability to work in a cleanroom environment
  • Standing for long periods of time
  • Bending
  • Sitting for long periods of time
  • Visual – Constant Visual attention
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